US not ready to approve Lilly's long-acting Zyprexa

Wed Jan 7, 2009 4:24pm EST
 
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WASHINGTON, Jan 7 (Reuters) - U.S. regulators have delayed a final decision on whether to approve Eli Lilly and Co's (LLY.N) long-acting form of its blockbuster schizophrenia drug Zyprexa, a Food and Drug Administration spokeswoman said on Wednesday.

The FDA has sent a "complete response" letter to Eli Lilly. The agency sends complete response letters to companies when it is not ready to approve a drug. It does not publicly disclose what steps are needed to win approval. (Reporting by Lisa Richwine, editing by Tim Dobbyn)

 

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