FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: EPIZYME, INC.; WITHDRAWAL OF APPROVAL OF NEW DRUG APPLICATION FOR TAZVERIK (TAZEMETOSTAT) TABLET, 200 MILLIGRAMS

WASHINGTON, June 22 -- Food and Drug Administration has issued a notice called: Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams.

The notice was published in the Federal Register on June 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for TAZVERIK (tazemetostat) tablet, 200 milligrams (mg), held by Epizyme, Inc, an Ipsen Company (Epizyme), 1 Main St, Cambridge, MA 02142. Epizyme has voluntarily requested withdrawal of its NDA and has waived the expedited withdrawal procedures.

For more information, contact Kimberly Leh...