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Negócios · 24/03/20221 min de leitura
Secura Bio, Inc.; Withdrawal of Approval of New Drug Application for FARYDAK (Panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and 20 Milligrams
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Resumo
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.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →