Skip to Content

Bifeprunox Approval Status

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 Status and FDA Approval Process for Bifeprunox

Aug 10, 2007Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. AnnounceReceipt 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.