FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: 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

WASHINGTON, Aug. 29 -- Food and Drug Administration has issued a notice called: 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.

The notice was published in the Federal Register on Aug. 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 requeste...