Sage Therapeutics Inc.’s (SAGE) lead product candidate, ZULRESSO injection for postpartum depression is under FDA review, with a final decision expected on March 19, 2019.Last November, an FDA panel voted 17-1 recommending approval of ZULRESSO. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.If approved, ZULRESSO is expected to be launched in the U.S. in June 2019, following expected scheduling by the Drug Enforcement Administration, which is to occur within 90 days of approval.ZULRESSO is an intravenous formulation of brexanolone, with a Breakthrough Therapy Designation in the U.S., and PRIority MEdicines (PRIME) designation in the European Union.If all goes well as planned, ZULRESSO would be the first medication indicated for the treatment of postpartum depression and would be Sage Therapeutics’ first commercial product.SAGE closed Tuesday’s trading at $152.76, down 4.15%.