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# FDA Approves Makena Generic
- URL: https://www.fdaweb.com/fda-approves-makena-generic/
- Published: 2019-01-02T12:00:00.000Z
- Updated: 2026-09-15T00:51:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143070

FDA has approved a Slayback Pharma ANDA for hydroxyprogesterone caproate injection 1,250 mg/5mL, a generic form of Amag Pharmaceuticals’ Makena, indicated to reduce the risk of preterm birth in some women. The company says it will soon launch its generic product, which is the only Makena generic approved by FDA.