Celgene and Teva Withdraw FDA Approval for Peripheral T-Cell Lymphoma Indication for ISTODAX and Romidepsin Injection

Summary

The US Food and Drug Administration (FDA) is withdrawing approval of peripheral T-cell lymphoma (PTCL) indication for ISTODAX (romidepsin) for injection and Romidepsin injection, following voluntary requests from Celgene Corporation and Teva Pharmaceuticals USA, Inc.