December 9, 2011

The Food and Drug Administration has approved a topical gel made by Antares Pharma for overactive bladder.

December 9, 2011

"I am appalled that politics has once again trumped science," wrote Brooklyn College Health Clinic director and nurse practitioner Ilene Tannenbaum in a letter to the New York Times. That reaction summed up much of the medical community's response to the Department of Health and Human Services' overruling of the Food and Drug Administration's decision to make the Plan B contraceptive pill a full nonprescription product.

December 8, 2011

A Food and Drug Administration panel of 13 advisers has voted in favor of a drug made by Pfizer for treating kidney cancer, the drug maker said Wednesday.

December 8, 2011

According to a report published Wednesday on the site of MobiHealthNews, the Food and Drug Administration has approved an iPhone glucose meter called AgaMatrix Nugget from Sanofi.

December 7, 2011

Five trade associations representing the dietary supplement industry on Tuesday collectively called for an overhaul of the Food and Drug Administration's draft guidance regarding new dietary ingredient reporting requirements.

December 7, 2011

A drug in late-stage clinical trials appears to treat the symptoms of autism, the drug's developer said Wednesday.

December 7, 2011

Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

December 7, 2011

At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

December 7, 2011

Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

December 7, 2011

The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B.

December 6, 2011

The Food and Drug Administration will decide on Wednesday whether to remove merchandising restrictions on the emergency contraceptive Plan B and allow the product to be merchandised in the front-end without age restrictions, according to a report published Monday in the Washington Post.

December 6, 2011

The Food and Drug Administration and the Federal Trade Commission on Tuesday issued seven warning letters to companies marketing over-the counter human chorionic gonadotropin products that are labeled as "homeopathic" for weight loss.

December 5, 2011

Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), a drug for treating symptoms of menopause, Mylan said it had received a patent license to begin selling its version of the drug in December 2013.


December 5, 2011

When someone says “pharmacy automation and technology,” the image that most likely springs to mind is a pharmacy robot dispensing pills in a bottle or pharmacists managing operations or looking at patients’ medical records and electronic prescriptions with the latest pharmacy software.


December 2, 2011

The Consumer Healthcare Products Association and the Council for Responsible Nutrition on Friday jointly filed comments with the Food and Drug Administration seeking withdrawal of its New Dietary Ingredient Draft Guidance, and calling upon the agency to work with stakeholders on a revised version that will maintain the current scope and intent of the Dietary Supplement Health and Education Act of 1994.

December 2, 2011

Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

December 2, 2011

At the request of the Food and Drug Administration, U.S. marshals on Thursday seized all dietary supplements manufactured by Syntec because of false claims made about the safety and effectiveness of their supplements in treating a number of diseases.

December 1, 2011

In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.

December 1, 2011

Ranbaxy Labs got the green light from the Food and Drug Administration Wednesday night to launch its generic version of Pfizer's cholesterol-lowering drug Lipitor.

December 1, 2011

Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.

November 30, 2011

The Food and Drug Administration on Tuesday appealed a recent District Court ruling that had placed a preliminary injunction on new, graphic anti-smoking messages that were to be placed on cigarette packaging as of September 2012.

November 30, 2011

Ranbaxy Labs was supposed to launch its generic version of the world's top-selling drug Wednesday, but a competitor beat it to the punch as the former waits for final Food and Drug Administration clearance.

November 29, 2011

A drug designed to prevent stroke and systemic embolism in patients with atrial fibrillation has been accepted for review by the Food and Drug Administration.

November 29, 2011

The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.