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FDA delays decision on Sage's postpartum depression drug by 3 months

Nov 20, 2018 - FierceBiotech

The FDA, which expected to approve or deny Sage Therapeutics' brexanolone next month, has pushed that decision off to March 19. The three-month delay will allow the agency to work on risk evaluation and mitigation strategies (REMS) to improve the treatment's safety. It did not ask Sage for additional data or information.

The delay comes two weeks after an advisory committee overwhelmingly backed the approval of brexanolone injection for the treatment of postpartum depression. The drug is a...