FDA Rejects Pfizer's Application to Sell Bextra 'Pro-Drug'

NEW YORK - The FDA has rejected an application by Pfizer Inc. for U.S. approval of the company's non-narcotic, injectable COX-2 inhibitor, parecoxib.

In a statement issued Sept. 20, Pfizer said it received a non-approval letter from the FDA indicating it would not permit sales of the drug, which is marketed in European countries under the trade name Dynastat, in the United States.

According to published reports, the FDA did not disclose reasons for denying Pfizer's application.

Parecoxib is a so-called 'pro-drug' of Pfizer's COX-2 inhibitor Bextra, which was pulled from pharmacy shelves in April after the FDA requested that …