Recently, Sage Therapeutics issued a statement saying that the FDA has extended the PDUFA date for priority review of new drug applications for its new drug Zulress (brexanolone) for the treatment of postpartum depression. This means that the previously disclosed PDUFA on December 19, 2018 will be extended by… Continue Reading FDA delays approval of new postpartum depression drug brexanolone, requiring risk assessment and mitigation strategies

Sage Therapeutics announced on May 30 that the FDA has accepted a new drug marketing application (NDA) for brexanolone (SAGE-547) intravenous injection to treat postpartum depression and granted priority review status. The PDUFA is scheduled to expire on December 19, 2018. Brexanolone is an allosteric modulator of the gamma-aminobutyric acid… Continue Reading The First Postpartum Depression New Drug Applicant Listed, Obtained FDA Priority Review Qualification