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商业 · 2026/6/221 分钟阅读

Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams

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摘要

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.

来源原始语言: Federal Register — Health and Human Services打开原始公告 →

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