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Abbott latest victim of FDA’s missed PDUFA dates

Executive Summary

Abbott Laboratories joins the ranks of pharma companies whose PDUFA action dates for NDAs have passed, as FDA told the company this week it needs more time to review its cholesterol drug TriLipix (ABT-335), a next-generation fenofibrate. The agency did not request additional data or extend the drug's PDUFA date. Abbott joins a long list of drug companies affected by the resource-strapped agency (1"The Pink Sheet," Sept. 29, 2008, p. 21). Abbott still expects a fourth quarter approval. It was a rough week for Abbott, as the company also received a complete response letter Oct. 20 from FDA for its NDA for a controlled-release form of hydrocodone with acetaminophen

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