FDA Approval Rate In ‘09 About Same As ‘08

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fdainthecrosshairs1The agency approved 26 new meds last year compared with 25 in 2008, a level that hadn’t been reached in five years, according to Dow Jones, which cites a report by Washington Analysis, a research firm. Newly approved meds included Effient, a blood thinner from Lilly and Daiichi Sankyo; Sanofi-Aventis’ Multaq heart pill, and two drugs to treat advanced kidney cancer: GlaxoSmithKline’s Votrient and Novartis’ Afinitor.

However, several drugs that had been expected to reach medicine cabinets never made it that far, as the agency delayed some approvals in search of additional info. An example: Amgen’s Prolia, or denosomab, for treating post-menopausal osteoporosis. Ira Loss, a healthcare analyst at Washington Analysis, says the FDA did a decent job approving drugs, but also missed key deadlines, which suggests more should be done improve the approval process. One thing, he says, slowed the works: the Risk Evaluation and Mitigation Strategies, or REMS programs designed to improve safety.

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