Opportunity
Federal Register #FDA-2026-N-6402
FDA Withdrawal of Approval for TAZVERIK (Tazemetostat) Tablet, 200 mg by Epizyme, Inc.
Buyer
Food and Drug Administration
Posted
June 22, 2026
Identifier
FDA-2026-N-6402
This notice announces the FDA's regulatory withdrawal of approval for a specific pharmaceutical product: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEM/Vendor: - Epizyme, Inc. (an Ipsen Company) - Product Affected: - TAZVERIK (tazemetostat) tablet, 200 mg - New Drug Application (NDA) withdrawn - Key Details: - Withdrawal was voluntarily requested by Epizyme, Inc. - Expedited withdrawal procedures were used - Action taken due to increased rate of second primary malignancies in a confirmatory clinical trial - Distribution of TAZVERIK (tazemetostat) tablet, 200 mg, without FDA approval is prohibited and subject to regulatory enforcement - No procurement, solicitation, or contract award is involved; this is a regulatory action only - No other OEMs, vendors, or products are mentioned
Description
The Food and Drug Administration (FDA) is withdrawing approval of the new drug application (NDA) for TAZVERIK (tazemetostat) tablet, 200 milligrams, held by Epizyme, Inc. Epizyme voluntarily requested the withdrawal and waived expedited withdrawal procedures. The withdrawal is effective as of June 22, 2026, due to increased rate of second primary malignancies observed in a confirmatory clinical trial. Distribution of TAZVERIK without an approved application is illegal and subject to regulatory action.