Celgene Corporation and Teva Pharmaceutical Industries Ltd.; Withdrawal of Approval of Peripheral T-Cell Lymphoma Indication for ISTODAX (Romidepsin) for Injection and Romidepsin Injection

摘要

The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the peripheral T-cell lymphoma (PTCL) indication for ISTODAX (romidepsin) for injection, approved under new drug application (NDA) 022393, held by Celgene Corporation, 86 Morris Ave., Summit, NJ 07901 (Celgene). We are also announcing the withdrawal of approval of the same indication for Romidepsin injection, approved under NDA 208574, held by Teva Pharmaceuticals USA, Inc., 400 Interpace Parkway, Building A, Parsippany, NJ 07054 (Teva). Celgene and Teva have voluntarily requested that FDA withdraw approval of this indication and have waived their opportunity for a hearing.