FDA Rejects Amylin Diabetes Drug Byetta, Seeks More Info

The U.S. Food and Drug Administration denied approval of a long-acting version of diabetes drug Byetta, sold by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., because the agency needs more information about the drug’s product label, risk-management plan and manufacturing process. The drug–commonly referred to as Byetta LAR, with a proposed brand name of Bydureon–is injected once a week as opposed to the twice-daily version on the market. It faces heavy competition in the diabetes market and the timing of its launch is seen as crucial to its eventual success.

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