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# Sage Postpartum Depression Oral Drug Approved
- URL: https://www.fdaweb.com/sage-postpartum-depression-oral-drug-approved/
- Published: 2023-08-07T12:00:00.000Z
- Updated: 2026-09-14T18:48:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155034

FDA has approved a Sage Therapeutics NDA for [Zurzuvae](http://email.prnewswire.com/ls/click?upn=OXp-2BEvHp8OzhyU1j9bSWuwMvMWelqIco5RbfBrouY-2BSAQHefOKn-2Fb9b0MP23OvJ0ZyFPsXRdKkDXMAuR0I9euzx51ZpGZJcmls7MswJh-2B12W8UsA0HioGKPrWer8IONurLAevMjYbMJpGLnjGgPaPtNnqFgDwH4nakP-2Fy0k-2Bd3rRw3TjqspefsQd8ILI5f4GUAqDmvf8fS7tXY2jGSVmfslopML8rXvJmnU3ue0qzMg-3DB7O8%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWVRkGckpnoFape93-2BY2CZKh0O1M6up9pwaH6-2FIfJclZlGALRw9dJCss0NGRQLWRDo11TOunoxf0SNrLhFhSS8FkKbr3pJe1Hfi8q8orCKyfDf7X-2FxZeojCy9fcZK9ZQbescOBMVcxL5CCtv1TO8ewlf8MytE-2BCcybCyk6R1RLcUcTJDsBTBhtr9-2Bvd5TnDcmAVLqFTWFUnkwi6-2BahC4TP3gamTQEm-2FQ6gBI7FoPJ3KfXVrFxhdRTnWBHux7SCVqvn0BMs5UQp1k-2BM91Y88IzVT6zKPJcFBTFOlbB1g2kmIcNU-3D&ref=fdaweb.com) (zuranolone), an oral drug for treating postpartum depression (PPD) in adults. “Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression?ref=fdaweb.com) says. The daily recommended dose for Zurzuvae is 50mg, and it should be taken once every day for 14 days.

Approval was based on data from two randomized, double-blind, placebo-controlled, multicenter studies. “Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups,” FDA says. “The treatment effect was maintained at Day 42 — four weeks after the last dose of Zurzuvae". On the safety side, the drug’s labeling contains a boxed warning about affecting a person’s ability to drive and perform other potentially hazardous activities. “To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae,” it says.

Meanwhile, Sage says FDA also issued a complete response letter on the NDA seeking approval as a treatment for major depressive disorder (MDD). The agency told the company that its filing did not provide substantial evidence of effectiveness to support zuranolone for treating MDD.