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Parecoxib FDA Approval Status

FDA Approved: No
Generic name: Parecoxib
Company: Pfizer Inc.
Treatment for: Pain

Parecoxib sodium is a non-narcotic injectable COX-2 selective analgesic for the treatment of acute pain.

In September 2005, Pfizer Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for parecoxib had not been approved.

Development timeline for Parecoxib

DateArticle
Sep 20, 2005Pfizer Receives FDA Non-Approvable Letter on Parecoxib

Further information

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