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비즈니스 · 2022. 5. 31.1 분 읽기
TG Therapeutics, Inc.; Withdrawal of Approval of New Drug Application for UKONIQ (Umbralisib Tosylate) Tablets, Equivalent to 200 Milligrams Base
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요약
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for UKONIQ (umbralisib tosylate) Tablets, equivalent to (EQ) 200 milligrams (mg) Base, held by TG Therapeutics, Inc., 3020 Carrington Mill Blvd., Morrisville, NC 27560. TG Therapeutics, Inc. (TGT) has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →