May 29, 2013

The Food and Drug Administration has approved a generic drug for incontinence made by Perrigo Co., the drug maker said.

May 23, 2013

Johnson & Johnson expects to file for Food and Drug Administration approval of more than 10 new drugs over the next four years, the drug maker said Thursday.

May 22, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Sandoz, the company said.

May 21, 2013

Nordic Naturals now is offering Pro EPA Elite, a powerful EPA-only concentrate available without a prescription, the company stated.

May 17, 2013

A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

May 15, 2013

The Food and Drug Administration has approved a drug for a type of lung cancer.

May 15, 2013

The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.

May 14, 2013

The Food and Drug Administration will review an experimental contraceptive patch made by Actavis, the drug maker said Tuesday.

May 13, 2013

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

May 9, 2013

One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

May 8, 2013

The Council for Responsible Nutrition and the Natural Products Association announced they have met with the entire freshman class of the 113th Congress, including 83 offices in the House of Representatives and 14 offices in the Senate, as part of their educational efforts to ensure that newly elected members of Congress have accurate information about dietary supplements and their role in good health.

May 8, 2013

Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

May 8, 2013

There is as much as $10 billion in branded pharmaceutical sales that could make the switch from prescription-only to over-the counter in the next five years, suggested Joseph Papa, Perrigo chairman, CEO and president, to analysts on Tuesday.

May 7, 2013

The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study.

May 6, 2013

An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

May 6, 2013

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

May 6, 2013

The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient.

May 2, 2013

The Justice Department reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

May 1, 2013

The Food and Drug Administration announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older.

April 30, 2013

The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

April 30, 2013

The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.

April 30, 2013

The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

April 30, 2013

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

April 29, 2013

A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.