07/29/2014 - 12:31pm

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 - 12:14pm

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 - 11:46am

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 - 2:14pm

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 - 8:43am

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 - 1:11pm

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 - 12:41pm

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 - 1:44pm

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.

07/21/2014 - 10:27am

Commentary published online Monday addresses the controversy surrounding the high costs of new Hepatitis C virus treatments and implications for the growing specialty pharmacy market.