← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEJune 22, 2026

Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams

Document type
Notice
Agency
Health and Human Services Department
Published
June 22, 2026
Document number
2026-12367
ABSTRACT

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.

Abstract as published in the Federal Register.

READ THE FULL DOCUMENT

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.

View on federalregister.gov →
PUT THIS CHANGE TO WORK
GxP HorizonWhere regulation is heading next →Decode the standardsThe requirements this rule touches →All regulatory changesBrowse the live Federal Register feed →

Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.