Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-6402] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. DATES: Approval is withdrawn as of June 22, 2026. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-796-3137, Kimberly.Lehrfeld@fda.hhs.gov . SUPPLEMENTARY INFORMATION: On January 23, 2020, FDA approved NDA 211723 for TAZVERIK (tazemetostat) tablet, 200 mg, for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, under the Agency's accelerated approval pathway pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ( 21 U.S.C. 356(c) ) and 21 CFR 314.510 . On June 18, 2020, FDA approved the following two new indications for TAZVERIK (tazemetostat) tablet, 200 mg, [ 1 ] also ( printed page 37121) under the accelerated approval pathway pursuant to section 506(c) of the FD&C Act…
Citation: 91 FR 37120
