federal_register: 2026-12367

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2026-12367 Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams Notice 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. 2026-06-22 2026 6 https://www.federalregister.gov/documents/2026/06/22/2026-12367/epizyme-inc-withdrawal-of-approval-of-new-drug-application-for-tazverik-tazemetostat-tablet-200 https://www.govinfo.gov/content/pkg/FR-2026-06-22/pdf/2026-12367.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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