The U.S. Food and Drug Administration approved TAZVERIK, a prescription oral tablet containing 200 mg of TAZEMETOSTAT HYDROBROMIDE, under NDA 213400.
The product, submitted by EPIZYME Inc., received priority review and carries an orphan drug designation. The original submission (submission number 1) was classified as Type 9 – New Indication Submitted as Distinct NDA, consolidated after approval.
The approval was documented on June 18 2020, with associated labeling, medication guide, and FDA correspondence available through the agency’s website.
Regulatory UpdatesSep 18, 2026•3 min read
FDA Grants Priority Approval to EPIZYME’s Orphan Drug TAZVERIK (TAZEMETOSTAT HYDROBROMIDE 200 mg)
The FDA approved TAZVERIK, a prescription oral tablet for EPIZYME Inc., under NDA 213400 with priority review and orphan designation.
Compiled by the Pharmacountry team · Source: FDA.gov
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