Pfizer, Inc.; Withdrawal of Approval of Familial Adenomatous Polyposis Indication for CELEBREX

الملخص

The Food and Drug Administration (FDA) is withdrawing approval of the familial adenomatous polyposis (FAP) indication for CELEBREX (celecoxib) Capsules held by Pfizer, Inc. (Pfizer), 235 East 42nd St., New York, NY 10017-5755. Pfizer has voluntarily requested that approval of this indication be withdrawn, thereby waiving its opportunity for a hearing.