01/08/2015 - 1:31pm

Camber Pharmaceuticals on Thursday announced the launch of valsartan tablets USP in 40-, 80-, 106- and 320-mg dosage strengths.

 

01/07/2015 - 3:25pm

With tens and possibly hundreds of billions of dollars in potential savings still snagged in a regulatory limbo, federal lawmakers and health industry stakeholders strongly urged the Food and Drug Administration last month to knock down the final barriers to review and approval of biosimilar drugs for marketing in the United States.

01/07/2015 - 10:18am

Teva Pharmaceutical on Tuesday announced the Food and Drug Administration approved the launch of the company's valsartan tablets, the generic version of Diovan tablets from Novartis. 

 

01/06/2015 - 2:09pm

Vermont Attorney General Bill Sorrell is investigating generic drug price inflation.

01/05/2015 - 3:24pm

The Consumer Healthcare Products Association thanked President Obama for signing the Designer Anabolic Steroid Control Act into law last month.

12/30/2014 - 11:17am

Vertex Pharmaceuticals has announced that the Food and Drug Administration approved a supplemental new drug application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

12/29/2014 - 11:26am

Genentech last week announced that the Food and Drug Administration approved a supplemental biologics license application for Gazyva to be used in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.

12/29/2014 - 10:46am

In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.

12/29/2014 - 10:29am

Novo Nordisk last week announced that the Food and Drug Administration approved the company's new drug application for Saxenda, a once-daily glucagon-like peptide-1 receptor agonist used as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults.