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# Panel to Review Makena ‘Unfavorable’ Study
- URL: https://www.fdaweb.com/panel-to-review-makena-unfavorable-study/
- Published: 2019-09-24T12:00:00.000Z
- Updated: 2026-09-15T01:52:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145075

*Federal Register* notice: FDA has announced a 10/29 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amag Pharmaceuticals supplemental NDA for Makena (hydroxyprogesterone caproate injection), 250mg/ml, for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Panel members will review results from a postapproval confirmatory clinical trial that was intended to verify and describe clinical benefit. Amag has disclosed that this completed confirmatory trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-23/pdf/2019-20543.pdf?ref=fdaweb.com).