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行业洞察美国 FDAT1064

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

·26 天前·来源:美国 FDA

🤖 AI 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.

分析模型:rule-based-v3 · 07-09 06:59

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综合分 64/100

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Federal Register: FDA Notices (官方通知)
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