FDA rejects Byetta data

Nov. 6, 2008 at 12:04 AM

WASHINGTON, Nov. 6 (UPI) -- The U.S. Food and Drug Administration has rejected research data for a long-acting version of the diabetes drug Byetta.

The FDA rejected Eli Lilly's studies comparing small-scale batches of Byetta LAR made by partner Alkermes to large-scale batches made at an Amylin Pharmaceuticals manufacturing plant, Amylin said. Conducting a new study could delay the company's plans to seek approval next year, the Indianapolis Star reported.

The version of Byetta currently on the market is a twice-a-day injectable drug to help diabetics control their blood sugar, the newspaper said.

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