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on Friday jointly filed comments with the Food and Drug Administration seeking withdrawal of its New Dietary Ingredient Draft Guidance, and calling upon the agency to work with stakeholders on a revised version that will maintain the current scope and intent of the Dietary Supplement Health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.

November 28, 2011

The Food and Drug Administration has approved a generic drug made by Mylan for cancer patients.

November 28, 2011

The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.

November 28, 2011

Perrigo on Monday announced that it received final approval from the Food and Drug Administration for its store-brand version of Mucinex tablets.

November 28, 2011

A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

November 23, 2011

The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

November 23, 2011

The Food and Drug Administration has approved a professional glucose monitoring system made by Medtronic, the company said.

November 23, 2011

British drug maker Shire is looking to make a biotech drug for a rare genetic disorder at a new manufacturing plant in Massachusetts.

November 21, 2011

A drug made by Amgen delayed the spread of prostate cancer to the bones in men with the disease and prolonged the survival of men with the condition, according to results of a late-stage clinical trial.