Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams
FDA withdraws approval of TAZVERIK (tazemetostat) tablet, 200 mg NDA held by Epizyme, Inc.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 30, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Epizyme, Inc. and any parties involved in manufacturing, distributing, or marketing TAZVERIK (tazemetostat) tablets, 200 mg. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective upon publication in the Federal Register (June 22, 2026).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA is withdrawing approval of the New Drug Application (NDA) for TAZVERIK (tazemetostat) tablet, 200 mg, meaning the drug is no longer approved for marketing in the U.S.
Who it affects
Epizyme, Inc. and any parties involved in manufacturing, distributing, or marketing TAZVERIK (tazemetostat) tablets, 200 mg.
What you must do
Epizyme must cease distribution and marketing of TAZVERIK tablets, 200 mg, and comply with FDA procedures for withdrawal, including potential recall or disposal of existing stock.
Deadline
Effective upon publication in the Federal Register (June 22, 2026).
Never miss a change like this again
Aforeworn watches Pharmaceutical Manufacturing (FDA/DEA) around the clock and alerts you the moment a rule moves — with a plain-English brief on what to do.
Start your free trialRelated changes in Pharmaceutical Manufacturing (FDA/DEA)
- Ordering Schedule I and II Controlled Substances Using DEA Form 222; Technical Amendments
- Schedules of Controlled Substances: Placement of 3-Methoxyphencyclidine (1-(1-(3-Methoxyphenyl)cyclohexyl)piperidine) in Schedule I
- Designation of P2P Methyl Glycidic Acid as a List I Chemical
- Specific Listing for Hexahydrocannabinol, A Currently Controlled Schedule I Substance
- Exempt Chemical Preparations Under the Controlled Substances Act