Fda articles

Ruxolitinib and tofacitinib restore hair in patients with alopecia areata
Researchers have identified the immune cells responsible for destroying hair follicles in people with alopecia areata, a common autoimmune disease that causes hair loss, and have tested an FDA-approved drug that eliminated these immune cells and restored hair growth in a small number of patients.

ReWalk - First and Only Exoskeleton Cleared by FDA in US
Exoskeleton leader ReWalk Robotics announced that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.

Cyramza for stomach cancer approved in US
Cyramza (ramucirumab) is approved to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

Laparoscopic power morcellation not right for removal of uterus or uterine fibroids
The U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.

Dexcom's G4 Platinum continuous glucose monitoring system approved for kids
The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.

US FDA bans 23andme direct to consumer genetic testing kit
The Food and Drug Administration, USA has ordered 23andme - the maker of a popular genetic-testing kit to stop sales of its heavily marketed product, saying the mail-order tests haven't been proven effective and could dangerously mislead people about their health.

Drug shortages to be solved in US says FDA
US FDA is taking two actions to further enhance the agency's ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients.

Avoid decorative and colored contact lenses this Halloween for eye safety
Decorative and colored contact lenses are extremely popular during Halloween as they enhance the costume. But, be aware that these lenses carry a significant health risk. U.S. Food and Drug Administration is discouraging consumers from using decorative contact lenses.

Chobani yogurt recalled - 170 fell sick
As of September 13, the FDA received a total of 170 complaints associated with Chobani. The various issues reported continue to be cramps, nausea, headache and diarrhea. The complaints were submitted by individuals in Arizona, Delaware, New York, Maryland, Ohio, Pennsylvania, California, Indiana and Florida.

Botox Cosmetic approved to improve crow's feet lines
A new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow's feet, in adults is approved in USA. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines.

Arsenic in rice and rice products is low
The levels FDA found in its testing are too low to cause immediate or short-term adverse health effects. FDA's work going forward will center on long-term risk and ways to manage it with a focus on long-term exposure.

Acetaminophen pain drug can cause rare serious skin reactions
Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).

Hepatitis A illnesses associated with a frozen fruit blend
Townsend Farms, Inc. of Fairview, Oregon, recalled certain lots of its frozen Organic Antioxidant Blend on June 4, 2013, because it has the potential to be contaminated with Hepatitis A virus. No other Townsend Farms products, frozen or fresh, are covered by this voluntary recall or linked to the illness outbreak at this time.

Morning After Pills to all ages allowed in US
An appeals court ordered the U.S. Food and Drug Administration to make certain forms of "morning-after" birth control pills available freely over the counter to anyone who wants to buy them.

Lymphoseek to locate lymph nodes in breast cancer or melanoma patients
The U.S. Food and Drug Administration approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Buphenyl a possible drug for Alzheimer's disease
Buphenyl, an FDA-approved medication for hyperammonemia, may protect memory and prevent the progression of Alzheimer's disease. Hyperammonemia is a life-threatening condition that can affect patients at any age. It is caused by abnormal, high levels of ammonia in the blood.

Anemia drug Omontys recalled due to anaphylaxis
In US, Omontys Injection is recalled due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients. Until further notice, health care providers should stop using Omontys.

Kadcyla - new treatment for late stage HER2 breast cancer
Kadcyla (ado-trastuzumab emtansine) - a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer is approved by US FDA. Breast cancer is the second leading cause of cancer-related death among women. Almost 20 percent of breast cancers have increased amounts of the HER2 protein.

Natrelle 410 silicone gel breast implants approved in US
The U.S. Food and Drug Administration approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc.

Generic version of cancer drug Doxil approved
The U.S. Food and Drug Administration approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection). Doxorubicin hydrochloride liposome injection is currently on the FDA?s drug shortage list.

Kynamro approved to treat inherited cholesterol disorder
Kynamro - mipomersen sodium - injection approved as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). Kynamro is approved by the U.S. Food and Drug Administration.

3 new drugs approved for type 2 diabetes in US
The U.S. Food and Drug Administration approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.

Flublok seasonal influenza vaccine approved in US
The U.S. Food and Drug Administration announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.

New US food safety standards for foodborne illness prevention and produce safety
The U.S. Food and Drug Administration proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days.

Sirturo - first drug to treat multi drug resistant tuberculosis
The U.S. Food and Drug Administration approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.

Fulyzaq - first anti diarrheal drug for HIV AIDS patients
The U.S. Food and Drug Administration approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.

Fungal meningitis outbreak in US due to NECC epidural steroid injection
A multistate outbreak of fungal meningitis among patients who received an epidural steroid injection with a potentially contaminated product has been notified in USA. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are currently coordinating the investigation of this outbreak of fungal meningitis.

Illegal Internet pharmacies - FDA acts
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.

Stribild once a day combination pill to treat HIV
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection, is approved in US by FDA.

Asthma and allergies drug Singulair as generic version approved
The U.S. Food and Drug Administration approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

Zaltrap for metastatic colorectal cancer approved by FDA
The U.S. Food and Drug Administration approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.

Food safety guides available for groups most vulnerable to foodborne illness
The U.S. Department of Agriculture?s Food Safety and Inspection Service (FSIS) and the Department of Health and Human Services? Food and Drug Administration (FDA) have partnered to create six booklets with food safety advice for populations that are most susceptible to foodborne illness.

Truvada approved to reduce HIV infection risk in uninfected
The U.S. Food and Drug Administration has approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.

HIV test kit OraQuick approved - first OTC In Home HIV Test
The U.S. Food and Drug Administration approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Belviq lorcaserin approved to treat overweight or obese adults
Belviq (lorcaserin hydrochloride) is approved as an addition to a reduced-calorie diet and exercise, for chronic weight management. This obesity drug is approved by US FDA for use in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

Bevacizumab with chemotherapy provides no survival benefit for lung cancer patients
Adding the drug bevacizumab (Avastin) to the standard chemotherapy regimen for non-small cell lung cancer (NSCLC) ? an approach approved by the FDA in 2006 ? did not lead to significantly increase survival rates for patients over the age of 65 enrolled in Medicare.

Safety changes in labeling for cholesterol lowering drugs statins
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced by the U.S. Food and Drug Administration. These products, when used with diet and exercise, help to lower a person's "bad cholesterol (low-density lipoprotein cholesterol).

2 new pancreatic enzyme products Ultresa and Viokace to aid food digestion
Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.

Bexarotene cancer drug may reverse Alzheimer's symptoms
Neuroscientists at Case Western Reserve University School of Medicine have made a dramatic breakthrough in their efforts to find a cure for Alzheimer's disease. The research shows that use of a drug in mice appears to quickly reverse the pathological, cognitive and memory deficits caused by the onset of Alzheimer's.

Erivedge approved for skin cancer metastatic basal cell carcinoma
Erivedge or vismodegib was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The Erivedge drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

Prevnar 13 vaccine approved for people ages 50 and older
Prevnar 13, a pneumonia vaccine, is approved for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

Eylea approved for AMD eye disorder in older people
The U.S. Food and Drug Administration approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.

Avastin bevacizumab approval revoked to treat breast cancer in US
US health agency FDA Commissioner Margaret A. Hamburg, M.D. has revoked the approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

35 new drugs approved in 2011 in US
Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines for patients, like two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin's lymphoma in 30 years; and the first new drug for lupus in 50 years.

Remicade infliximab approved to treat ulcerative colitis in children
The U.S. Food and Drug Administration approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.

Chloroflouorocarbons OTC asthma inhalers will no longer be made or sold in US
The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec_31, 2011.

Listeria monocytogenes on Jensen Farms Rocky Ford brand cantaloupes confirmed
US Food and Drug Administration announced that it found Listeria monocytogenes in samples of Jensen Farms' Rocky Ford-brand cantaloupe taken from a Denver-area store and on samples taken from equipment and cantaloupe at the Jensen Farms' packing facility.

Do not eat Rocky Ford Cantaloupe shipped by Jensen Farms US
US FDA is warning consumers not to eat Rocky Ford Cantaloupe shipped by Jensen Farms of Granada, Colo. The majority of the patients reported eating cantaloupe marketed from the Rocky Ford growing region. FDA's traceback data from the State of Colorado about their confirmed cases of Listeria monocytogenes have identified a common producer of Rocky Ford cantaloupes. That producer is Jensen Farms. Although the investigation is ongoing, no other Rocky Ford cantaloupe producer has been found in common in the Colorado traceback.

Multistate outbreak of Listeria in US
The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and state health agencies to investigate a multi-state outbreak of listeriosis.

Label change expected for osteoporosis drugs Fosamax, Actonel and Boniva
A US FDA advisory committee wants the health agency FDA to limit the duration of bisphosphonate therapy for treatment of osteoporosis. The panel could not agree on what that time limit should be. The panel also endorsed a label change for osteoporosis drugs.

Adcetris approved to treat two types of lymphoma
The U.S. Food and Drug Administration recently approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).

Zelboraf approved for late stage skin cancer
The U.S. Food and Drug Administration recently approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

Scorpion stings treatment Anascorp approved in US
The U.S. Food and Drug Administration approved Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the United States.

FDA panel votes to revoke approval for Avastin for advanced breast cancer
The Oncologic Drugs Advisory Committee, FDA, USA disapproved the Avastin which cited a lack of survival benefit. Now as two more trials have been analyzed -- neither showing a survival benefit -- the FDA stated that in the balance, the benefit did not outweigh the harm.

Inform Dual ISH to determine HER2 gene in breast cancer patients
Breast cancer is the second leading cause of cancer-related death among women. About 20 percent of women diagnosed with breast cancer are HER2-positive. The Inform Dual ISH test allows lab personnel to count the number of copies of HER2 genes on chromosome 17 in a small sample of the breast tumor. Copies of the HER2 gene appear black and copies of chromosome 17 appear red. Patients with more than the normal number of copies of the HER2 gene are considered candidates for Herceptin therapy.

Better inform consumers about sunscreen to help reduce skin cancer risk, early aging
Sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn. The final regulation allows sunscreen products that pass the FDA's test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as "Broad Spectrum."

New safety recommendations for high dose 80 mg simvastatin
Patients taking simvastatin 80 mg daily had an increased risk of muscle injury. The risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury or myopathy.

Incivek for hepatitis C infection is approved in US
The U.S. Food and Drug Administration approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies.

Many new drugs did not have comparative effectiveness information
Only about half of new drugs approved in the last decade had comparative effectiveness data available at the time of their approval by the U.S. Food and Drug Administration, and approximately two-thirds of new drugs had this information available when alternative treatment options existed,.

Zytiga approved for late stage prostate cancer
The U.S. Food and Drug Administration approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).

Vaccine to prevent meningococcal disease in infants and toddlers
The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

US plans to reduce harm from opioid drugs
The White House on Tuesday unveiled a multi-agency plan aimed at reducing the "epidemic" of prescription drug abuse in the U.S.-including an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.

Use of atypical antipsychotics in treatment of dementia declined in US
A warning issued by the Food and Drug Administration regarding the use of atypical antipsychotics for the treatment of dementia was associated with a significant decline in the use of these medications for treating dementia symptoms in elderly patients.

Breast implants linked to ALCL a rare cancer
Saline and silicone gel-filled breast implants are linked to anaplastic large cell lymphoma (ALCL), a very rare type of cancer, announced by US Health Agency FDA.

Acetaminophen not more than 325 mg in each dose
The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

Tiny Greens Brand Alfalfa Sprouts or Spicy Sprouts may contain Salmonella
US FDA is advising consumers not to eat Alfalfa Sprouts and Spicy Sprouts (which contain alfalfa sprouts mixed with radish and clover sprouts) from Tiny Greens Organic Farm of Urbana, Ill.

Gardasil approved to prevent anal cancer
The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

US company starts clinical trial using stem cells to treat macular degeneration
Advanced Cell Technology, Inc. ("ACT"; OTCBB:ACTC) announced that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt's Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world.

Warning Letters to caffeinated alcoholic beverages, US
The U.S. Food and Drug Administration warned four companies that the caffeine added to their malt alcoholic beverages is an "unsafe food additive" and said that further action, including seizure of their products, is possible under federal law.

Avandia use is restricted for diabetes patients
FDA will restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. Avandia may elevate risk of cardiovascular events, such as heart attack and stroke.

Eggs recalled in US due to Salmonella risk
An outbreak of Salmonella Enteritidis (SE) that has sickened hundreds of people across the US has led to a recall of shell eggs. Working closely with the Centers for Disease Control and Prevention (CDC) and state public health partners, the FDA reviewed epidemiologic and environmental investigation documents and identified 3 best-case clusters of Salmonella Enteritidis illnesses.

Prolia - new injectable osteoporosis treatment for postmenopausal women
The U.S. Food and Drug Administration approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Weight loss drug orlistat may lead to liver injury
The U.S. Food and Drug Administration advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.

Long term use of heartburn drugs linked to fractures
The U.S. Food and Drug Administration warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors.

Use broad spectrum sunscreen to protect against UV rays
Sunscreen active ingredients, which are compounds that absorb, scatter or reflect ultraviolet (UV) light, are regulated as over-the-counter (OTC) drugs by the U.S. Food and Drug Administration (FDA).

Candy like nicotine products could lead to accidental poisoning
A tobacco company's new, dissolvable nicotine pellet--which is being sold as a tobacco product, but which in some cases resembles popular candies--could lead to accidental nicotine poisoning in children, according to a new study from the Harvard School of Public Health (HSPH), the Northern Ohio Poison Control Center, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).

Safety concern for HIV drug combination
The U.S. Food and Drug Administration announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart.

FDA reviewing Avandia, rosiglitazone and cardiovascular safety
The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia (rosiglitazone).

New safety controls for asthma drugs, US
The U.S. Food and Drug Administration announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults.

New safety plan for agents used to treat chemotherapy related anemia
The U.S. Food and Drug Administration today approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs).

Counterfeit weight loss drug Alli containing sibutramine
The U.S. Food and Drug Administration (FDA) is updating its warning to the public about a counterfeit version of Alli 60 mg capsules (120 count refill pack) being sold over the internet, particularly at online auction sites.

Victoza, liraglutide approved for type 2 diabetes
Novo Nordisk announced that the US Food and Drug Administration (FDA) has granted marketing authorisation for Victoza for the treatment of type 2 diabetes in adults.

Ampyra, dalfampridine approved for multiple sclerosis patients
The U.S. Food and Drug Administration approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS).

Actemra, tocilizumab approved for Rheumatoid Arthritis
Genentech, Inc. , a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA? (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Kalbitor, ecallantide, approved for treating hereditary angioedema
The U.S. Food and Drug Administration approved Kalbitor (ecallantide) to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

Red Ribbon Express launched on World Aids Day
Smt. Sonia Gandhi, Chairperson UPA and Chairperson Rajiv Gandhi Foundation flagged off the Red Ribbon Express from Safdarjung Railway Station to commemorate the World AIDS Day.

Novartis' Agriflu seasonal influenza vaccine approved in US
The U.S. Food and Drug Administration approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

H1N1 vaccines to include infants and children
US FDA has approved the use of the CSL Limited's 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

FDA should ensure food safety measures in US
Most Americans support for measures that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick.

Breast cancer drugs may prevent cervical cancer also
Researchers eliminated cervical cancer in mice with two FDA-approved drugs currently used to treat breast cancer and osteoporosis. The study is published in the Proceedings of the National Academy of Sciences.

FDA declines Fusilev NDA for colorectal cancer
A Complete Response letter is issued by the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection for treatment of patients with advanced metastatic colorectal cancer.

Eurand's Zenpep pancreatic enzyme product approved by FDA
U.S. Food and Drug Administration (FDA) has approved Eurand's New Drug Application (NDA) for ZENPEP(TM) (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.

TNF blockers will have boxed warning cancer risk
The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers or TNF inhibitors.

Another test for 2009 H1N1 influenza virus
The U.S. Food and Drug Administration announced it has issued an Emergency Use Authorization (EUA) for a another diagnostic test for the 2009 H1N1 influenza virus, whose spread has caused the virus to be characterized as a pandemic by the World Health Organization.

Seasonal influenza vaccine for 2009-2010 approved by US
The U.S. Food and Drug Administration announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States. The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus.

Young You recalls weight loss pills
Young You Corporation has been informed by the Food and Drug Administration (FDA) that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient.

Effient to reduce heart attack risk in angioplasty patients
The U.S. Food and Drug Administration has approved the Eli Lilly's blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery.

Lilly's lung cancer drug Alimta is approved in US
Eli Lilly's lung cancer drug Alimta (pemetrexed) -- the first drug available for maintenance therapy of advanced or metastatic lung cancer, is approved by the U.S. Food and Drug Administration, USA.

Sanofi's Multaq approved to treat heart rhythm disorder, US
The U.S. Food and Drug Administration has approved Sanofi's Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders or arrhythmia).

Boxed warning required for Chantix and Zyban, says FDA
Smoking cessation drugs Chantix and Zyban are causing unusual changes in behavior, depression, and suicidal thinking in those who have taken these drugs to quit their smoking habits.

Takeda's diabetes drug alogliptin received FDA's objection
US top most health agency FDA has asked Takeda to conduct an additional clinical trial to rule out any adverse effects of alogliptin in relation to heart, that means Takeda needs to conduct a cardiovascular safety trial for alogliptin.

Improve contact lens safety, says US FDA
The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures.

Certain Zicam cold remedies linked to loss of sense of smell
The U.S. Food and Drug Administration advised consumers to stop using three products marketed over-the-counter (OTC) as cold remedies because they are associated with the loss of sense of smell (anosmia).

FDA reviewing stimulant medications for ADHD
U.S. Food and Drug Administration (FDA) issues safety communication about an ongoing review of stimulant medications used in children with ADHD (Attention deficit hyperactivity disorder).

Check your Levemir insulin XZF0036, XZF0037, XZF0038
Novo Nordisk product previously reported as stolen in North Carolina has resurfaced recently at a medical center in Houston.

FDA warns consumers not to use skin care products by Clarcon
The U.S. Food and Drug Administration announced that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection.

Option Inferior Vena Cava Filter gets FDA clearance in US
Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in the United States, for use in both permanent and retrievable indications.

Eye wrinkles removal laser device gets OTC
US health agency FDA (Food and Drug Administration) approved over-the-counter (OTC) marketing of Palomar's laser device for treatment of wrinkles around the eyes, i.e. periorbital wrinkles.

Complete response letter for Cinryze for hereditary angioedema
ViroPharma Incorporated (Nasdaq: VPHM) announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to its supplemental Biologics License Application (sBLA) for Cinryze(TM) (C1 esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE).

FDA forms Transparency Task Force
The U.S. Food and Drug Administration (FDA) announced the formation of a task force to develop recommendations for enhancing the transparency of the agency's operations and decision-making process.

$1 M grants to enhance food and feed safety, US
The U.S. Food and Drug Administration recently enhanced its food and feed protection initiatives with the award of three one-year Food Safety and Security Monitoring grants totaling $1 million to the states of Arkansas, Nebraska, and Wisconsin. The funds support cooperative agreements designed to create a national integrated food safety system through enhanced federal and state collaboration in food emergency response activities.

Palladia approved to treat cancer in dogs
The U.S. Food and Drug Administration announced the approval of Palladia (toceranib phosphate), the first drug developed specifically for the treatment of cancer in dogs.

Besivance eye drop approved to treat bacterial conjunctivitis
The U.S. Food and Drug Administration approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes.

Risperdal Consta approved for bipolar disorder
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Applications (sNDAs) for the use of RISPERDAL? CONSTA? (risperidone) Long-Acting Treatment as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of Bipolar I Disorder.

UCB's Cimzia approved for rheumatoid arthritis adults
UCB announced that the U.S. Food and Drug Administration (FDA) approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Children's face paint associated with adverse events
The Food and Drug Administration is advising consumers to stop using certain cosmetic "Face Paint" items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide.

Fanapt iloperidone approved for schizophrenia treatment
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the US Food and Drug Administration (FDA) has granted marketing approval of Fanapt (iloperidone) for the acute treatment of adult patients with schizophrenia.

Sanofi Pasteur's New Influenza Vaccine Plant, US
Sanofi Pasteur, the vaccines division of sanofi-aventis Group (Euronext: SAN) (NYSE: SNY), announced that the U.S. Food and Drug Administration (FDA) has licensed its new influenza vaccine manufacturing facility.

Avastin approved for brain cancer Glioblastoma
Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with glioblastoma with progressive disease following prior therapy.

New drug to improve walking ability in multiple sclerosis people
Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced that the U.S. Food and Drug Administration (FDA) has accepted the Fampridine-SR New Drug Application (NDA) for filing, assigning Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October_22, 2009.

Stop Using Hydroxycut Dietary Supplements for weight loss
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

New tools to study H5N1 vaccines for Bird Flu
An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus.

Plan B as OTC for 17 year old women
The Food and Drug Administration (FDA) announced that it will not appeal a U.S. District Court order that 17 year old girls should have unrestricted, over-the-counter access to Plan B or so-called "emergency contraception."

Strides received US FDA approval for Lamivudine and Stavudine
Strides Arcolab Limited (Strides) announced that it has received tentative approval from the United States ? Food and Drug Administration for one new drug application (NDA) for fixed dose combination of Lamivudine and Stavudine Tablets 150 mg / 30 mg under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR).

Setton Pistachio contaminated with Salmonella
The FDA and the California Department of Public Health (CDPH) are investigating Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc, Calif.

Westco products linked to recalled peanuts, US
The U.S. Food and Drug Administration (FDA) is warning consumers not to consume any peanuts or peanut-derived products sold by Irvington, New Jersey-based Westco Fruit and Nuts Inc. (Westco/Westcott) due to possible Salmonella contamination.

Takeda's Uloric febuxostat approved for hyperuricemia in gout
Teijin Pharma Limited and Takeda Pharmaceutical Company Limited announced that on February 13, 2009, Takeda Pharmaceuticals North America, Inc., received FDA marketing approval for ULORIC (febuxostat) for the chronic management of hyperuricemia in patients with gout.

ATryn from milk of goats approved to treat hereditary antithrombin deficiency
The U.S. Food and Drug Administration issued its first approval for a biological product produced by genetically engineered (GE) animals.

PCA distributed peanut butter even after positive Salmonella test
A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) have enabled FDA to confirm that the sources of the outbreak of illnesses caused by Salmonella Typhimurium are peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia processing plant.

FDA and CDC recommendations for consumers using peanut products
US consumers are urged to check FDA's web site - www.fda.gov - to determine which products have been recalled and will be recalled in the coming days.

Human clinical trial of embryonic stem cell therapy approved
Geron Corporation (Nasdaq: GERN) announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.

Milnacipran for management of fibromyalgia approved
Pierre Fabre Laboratories announced that the Food and Drug Administration (FDA) has just approved the marketing application filed by Forest Laboratories, Inc. and Cypress Bioscience, Inc. for Milnacipran.

Update on FDA's Investigation of Salmonella outbreak in US
The Food and Drug Administration (FDA) is conducting a very active and dynamic investigation into the source of the Salmonella Typhimurium outbreak.

Leptin sensitizing agents may help to lose weight
The discovery more than a decade ago of leptin, an appetite-suppressing hormone secreted by fat tissue, generated headlines and great hopes for an effective treatment for obesity. But hopes dimmed when it was found that obese people are unresponsive to leptin due to development of leptin resistance in the brain. Now, researchers at Children's Hospital Boston report the first agents demonstrated to sensitize the brain to leptin: oral drugs that are already FDA-approved and known to be safe. Findings were published January 7 by the journal Cell Metabolism.

FDA will review Daiichi Sankyo, Lilly drug Prasugrel for heart attack
Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) confirmed that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during an advisory committee hearing on February_3, 2009.

Latisse approved for hypotrichosis of eyelashes
Allergan, Inc. (NYSE: AGN) announced that the U.S. Food and Drug Administration (FDA) has approved LATISSE(TM) (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes.

Complete Response Letter on Seroquel XR for major depressive disorder
AstraZeneca announced the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information for the supplemental New Drug Application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of Major Depressive Disorder (MDD) in adult patients.

Diet Coke Plus violating US FDA food safety law
The US Food and Drug Administration (FDA) reviewed the label for Diet Coke Plus 20 FL OZ (1.25 PT) 591ml. Based on the review, FDA concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Weight loss pills may be risky for health
The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk.

14 drugs identified for off label use
Physicians and policy-makers know that drugs are frequently prescribed to treat certain diseases despite a lack of FDA approval - a practice known as off-label prescribing. Yet they say the problem is so big they don't know how to begin tackling it.

Mislabeled ReliOn Insulin Syringes recalled in US
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling.

Updated labeling for psoriasis drug Raptiva approved
The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab).

US FDA assessed melamine and melamine compounds in food
The U.S. Food and Drug Administration (FDA) issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.

US to bulk purchase BioThrax anthrax vaccine from Emergent BioSolutions
Emergent BioSolutions Inc. (NYSE:EBS) announced that it has signed a new, multi-year, firm fixed price contract with the U.S. Department of Health and Human Services (HHS) to supply an additional 14.5 million doses of BioThrax(R) (Anthrax Vaccine Adsorbed), its FDA licensed anthrax vaccine, for inclusion in the Strategic National Stockpile (SNS).

Statins do not increase risk of Lou Gehrig's Disease
A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

Eli Lilly's Alimta approvad for lung cancer
Eli Lilly and Company (NYSE: LLY) announced that it received approval from the U.S. Food and Drug Administration (FDA) for the use of ALIMTA(R) (pemetrexed for injection), in combination with cisplatin, in the first-line treatment of locally-advanced and metastatic non-small cell lung cancer (NSCLC), for patients with nonsquamous histology.

Trials supporting FDA approved drugs remained unpublished
Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week's PLoS Medicine. The most important trials determining efficacy, and those with statistically significant results and larger sample sizes, are more likely to be published.

Health expert urges FDA to take action to reduce BPA exposure
Researchers found a significant relationship between urine concentrations of the environmental estrogen bisphenol A (BPA) and cardiovascular disease, type 2 diabetes and liver-enzyme abnormalities.

Nplate bone marrow stimulator approved to treat low platelet counts
The U.S. Food and Drug Administration approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

Boxed warnings on fluoroquinolone antimicrobial drugs
The U.S. Food and Drug Administration (FDA) requests boxed warnings on fluoroquinolone antimicrobial drugs. FDA seeks this to strengthen warnings concerning increased risk of tendinitis and tendon rupture.

SPOT-Light HER2 CISH kit approved for breast cancer patients
SPOT-Light HER2 CISH kit - a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab) has been approved by the U.S. Food and Drug Administration.

FDA should take steps to challenge bogus immunity claims
US Center for Science in the Public Interest (CSPI) urges FDA to crack down on food frauds saying that Kraft, General Mills, Dole, & others ripping off consumers with bogus immunity claims.

US Food Protection Plan shows significant progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007.

Avoid raw red tomatoes in New Mexico, Texas
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes.

New drug labels better for pregnant & nursing mothers
New drug labeling system would provide better information about any prescription drug to pregnant women and nursing mothers as FDA proposes new rule to provide updated information on the use of prescription drugs and biological products during pregnancy and breast-feeding.

FDA to establish offices in China
In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.

Tussionex cough medicine with hydrocodone warning
The U.S. Food and Drug Administration issued an alert on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.

Genentech's Avastin with chemotherapy approved for advanced breast cancer
Genentech, Inc. (NYSE: DNA) announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Avastin (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer.

Guidelines for information on unapproved uses of medical products
The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

Baxter's multiple-dose vial Heparin causing allergy
The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

First decellularized heart valve approved in US
CryoLife, Inc., (NYSE: CRY) a biomaterials, medical device and tissue processing company, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its CryoValve(R) SG pulmonary human heart valve processed with the Company's proprietary SynerGraft technology.

Adverse reactions linked to Botox use, warns FDA
The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

FDA updates guidance to seafood processors after recent ciguatera poisoning
The U.S. Food and Drug Administration (FDA) issued a letter to seafood processors, advising them of recent illnesses linked to consuming fish carrying the ciguatera toxin, which has led to cases of ciguatera fish poisoning (CFP) in consumers.

Pfizer's anti smoking Chantix latest safety information
Chantix (varenicline), a prescription medication used to help patients stop smoking reported to have certain adverse effects like changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior. US FDA issued a Public Health Advisory to alert health care providers, patients, and caregivers.

Epilepsy drugs may raise suicide risk, warns FDA
An increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions, reported by U.S. Food and Drug Administration (FDA).

Ongoing review of cholesterol drug Vytorin
The U.S. Food and Drug Administration (FDA) is informing the public that the agency will conduct a review of Merck and Schering Plough's recent trial once the FDA receives the final study results.

Stricter warnings for botox, myobloc botulinum injections
The Food and Drug Administration (FDA) should immediately increase its warnings and directly warn patients and doctors about the use of botulinum toxin ? available as Botox and Myobloc ? because of serious adverse reactions, including deaths, linked to the drug, Public Citizen said in a petition filed with the FDA.

Prodesse's ProFlu+ Test for Respiratory Viruses receives FDA clearance
Prodesse, Inc., the leader in multiplex real-time PCR for infectious disease, announced that it received clearance from the U.S. Food and Drug Administration (FDA) to market its ProFlu+? Assay.

Intelence, etravirine HIV Drug approved in US
US FDA approved Tibotec Therapeutics' Intelence, etravirine tablets for the treatment of HIV infection, to be used in combination with other anti-HIV medications, in adults who have failed treatment with other antiretrovirals.

Ortho Evra contraceptive transdermal birth control patch label update
The U.S. Food and Drug Administration (FDA) approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.

Consumer Healthcare supports FDA over OTC cough and cold medicines withdrawal
On behalf of the leading makers of over-the-counter (OTC) cough and cold medicines, the Consumer Healthcare Products Association (CHPA) offered its support for U.S. Food and Drug Administration (FDA) decision against the use of oral OTC cough and cold medicines in children under the age of two.

Use OTC cough and cold products with care
US health agency FDA is recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.

Osteoporosis drugs increase bone necrosis risk
A popular class of osteoporosis drugs, bisphosphonates nearly triples the risk of developing bone necrosis, a condition that can lead to disfigurement and incapacitating pain, revealed by researchers in a study. The research conducted by reasearchers at the University of British Columbia and Vancouver Coastal Health Research Institute, Canada.

Quick Test For Drug-Resistant Staph Infections MRSA
The U.S. Food and Drug Administration (FDA) announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.

Safety warning on fentanyl skin patch by US FDA
The US Food and Drug Administration issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, the agency issued a similar warning to the public and to health care providers, saying that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose.

Potential drugs for mental retardation and autism treatment
Researchers at MIT's Picower Institute for Learning and Memory have corrected key symptoms of mental retardation and autism in mice. The work, which will be reported in the Dec. 20 issue of Neuron, indicates that a certain class of drugs could have the same effect in humans. These drugs are not yet approved by the FDA, but will soon be entering into clinical trials.

New warning for nonoxynol 9 OTC contraceptives in US
The U.S. Food and Drug Administration (FDA) issued a final rule that requires that manufacturers of over-the-counter (OTC) stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) include a warning that the chemical N9 does not provide protection against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs).

Swad brand sindoor contains high levels of lead
The U.S. Food and Drug Administration is warning consumers not to use 3.5 oz. packages of Swad brand sindoor, an orange or red powder used in some traditional South Asian Pacific ceremonies that is applied to the face or scalp, imported by Raja Foods LLC of Skokie, Illinois because the product contains high levels of lead. Although the product was not intended to be sold for food use, its labeling is confusing and implies that it may be used as food.

Reduce excess salt in food
In an effort to reduce the burden of heart disease and stroke, the American Medical Association (AMA) testified to the Food and Drug Administration urging immediate action to reduce excess salt in food. The AMA asked the FDA to set strict limits on salt in processed foods and work to better educate the public on the benefits of a low-sodium diet.

179 Fda articles listed above.

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