07/30/2014 - 10:58am

Perrigo on Wednesday announced that it has filed an abbreviated new drug application with the Food and Drug Administration for desoximetasone topical spray 0.25%. The company also has notified Taro Pharmaceuticals U.S.A., the owner of the reference listed drug, of the filing.

07/29/2014 - 1:31pm

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

07/29/2014 - 1:14pm

The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday.

07/28/2014 - 12:46pm

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.

07/23/2014 - 3:14pm

Generics supplier Camber Pharmaceuticals added two new executives to its team this week, bringing on Kirk Hessels as marketing director and Amanda Rebnicky as its sales operations director.

07/23/2014 - 9:43am

Mylan on Wednesday announced that U.S. District Court for the district of New Jersey granted a temporary restraining order against Apotex Inc. and Apotex Corp. relating to Paroxetine CR.

07/22/2014 - 2:11pm

Lupin, along with certain U.S. drugmakers and private equity funds, mght be making plans to bid for a selection of older drugs from GlaxoSmithKline, according to Reuters, which cited sources familiar with the dealings.

07/22/2014 - 1:41pm

The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical for abacavir sulfate and lamivudine tablets, according to agency records.

07/21/2014 - 2:44pm

The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced.