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Bifeprunox FDA Approval Status

FDA Approved: No
Generic name: Bifeprunox
Company: Solvay Pharmaceuticals, Inc.
Treatment for: Schizophrenia

Bifeprunox is an investigational atypical antipsychotic for the treatment of schizophrenia.

In August 2007, Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. announced the receipt of a Not Approvable Letter from the FDA advising the companies that the New Drug Application (NDA) for bifeprunox had not been approved.

Development timeline for Bifeprunox

Aug 10, 2007Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. Announce Receipt of an FDA Action Letter for Bifeprunox, an InvestigationalTreatment for Schizophrenia
Dec 12, 2006U.S. Food and Drug Administration Files New Drug Application for Bifeprunox, Submitted in October 2006
Oct 12, 2006Solvay Pharmaceuticals and Wyeth Announce Submission of New Drug Application for Bifeprunox to Treat Schizophrenia

Further information

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