January 22, 2013

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 16, 2013

The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

January 9, 2013

One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

December 28, 2012

Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

December 28, 2012

Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

December 28, 2012

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

December 18, 2012

Drug maker Merz Pharmaceuticals is suing Par Pharmaceutical over the latter's attempt to market a generic drug for cerebral palsy patients, according to published reports.

November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


November 5, 2012

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis.

October 23, 2012

A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

October 22, 2012

The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

October 15, 2012

Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, has received Food and Drug Administration approval on its abbreviated new drug application for irbesartan tablets — the generic equivalent to Sanofi's Avapro — in the 75-mg, 150-mg and 300-mg strengths.

October 2, 2012

Drug makers Takeda Pharmaceutical and H. Lundbeck have applied with the Food and Drug Administration for a new drug to treat depression in adults.

September 4, 2012

The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain cancer in children, the agency said.

August 30, 2012

The Food and Drug Administration has approved a new drug for treating bowel diseases made by Ironwood Pharmaceuticals, the agency said Thursday.

August 30, 2012

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

August 29, 2012

The Food and Drug Administration has approved a supplemental new drug application for an opioid analgesic to treat diabetes-related pain.

August 23, 2012

A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

August 13, 2012

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

July 27, 2012

Horizon Pharma announced it has received regulatory approval from the Food and Drug Administration for one of its drugs.

July 13, 2012

The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the drug maker said Friday.

June 28, 2012

Mylan is challenging the patent protection on a Pfizer drug for treating depression, following an announcement of a similar challenge by Watson made earlier this week.

June 25, 2012

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.

June 14, 2012

Stiefel, a GlaxoSmithKline company, on Monday acquired the eczema remedy Toctino (alitretinoin) from Basilea Pharmaceutica.