FDA drug approvals reach 16-year high in 2012

01/2/2013 | Reuters · Bloomberg

The FDA approved 39 new drugs in 2012, the most since 1996, suggesting growth prospects for branded drugmakers that have been losing business to patent expirations. The approvals included potential blockbuster drugs such as Pfizer and Bristol-Myers Squibb's blood thinner Eliquis, but many are intended for smaller markets, including Vertex Pharmaceuticals' Kalydeco, which treats a particular form of cystic fibrosis. The Prescription Drug User Fee Act "provided critical resources for improving the quality and timeliness of premarket review of drugs," FDA spokeswoman Sandy Walsh said.

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