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비즈니스 · 2022. 3. 24.1 분 읽기
Secura Bio, Inc.; Withdrawal of Approval of New Drug Application for FARYDAK (Panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and 20 Milligrams
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for FARYDAK (panobinostat) Capsules, 10 milligrams (mg), 15 mg, and 20 mg, held by Secura Bio, Inc., 1995 Village Center Circle, Suite 128, Las Vegas, NV 89134. Secura Bio, Inc. 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 →