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Entreprise · 29/08/20251 min de lecture
Amylyx Pharmaceuticals, Inc.; Withdrawal of Approval of New Drug Application for RELYVRIO (Sodium Phenylbutyrate and Taurursodiol) for Suspension, 3 Gram/Packet and 1 Gram/Packet
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Résumé
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for RELYVRIO (sodium phenylbutyrate and taurursodiol) for suspension, 3 gram (g)/ packet and 1 g/packet, held by Amylyx Pharmaceuticals, Inc. (Amylyx), 43 Thorndike St., Cambridge, MA 02141. Amylyx has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →