İş dünyası · 02.05.20221 dk okuma
Acrotech Biopharma LLC; Withdrawal of Approval of New Drug Application for MARQIBO (VinCRIStine Sulfate LIPOSOME Injection), 5 milligrams/5 milliliters
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Özet
The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for MARQIBO (vinCRIStine sulfate LIPOSOME injection), 5 milligrams (mg)/5 milliliters (mL), held by Acrotech Biopharma LLC (Acrotech), 29 Princeton Hightstown Rd., East Windsor, NJ 08520. Acrotech has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.