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Entreprise · 09/07/20121 min de lecture
Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules
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Résumé
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for DURACT (bromfenac sodium) Capsules, held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box 8299, Philadelphia, PA 19101-8299. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →