> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Final Withdrawal Decision on Makena Published
- URL: https://www.fdaweb.com/final-withdrawal-decision-on-makena-published/
- Published: 2023-05-12T12:00:00.000Z
- Updated: 2026-09-14T18:31:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154436

*Federal Register* notice: FDA is announcing its final decision rendered last month to withdraw approval of Covis Pharma Group’s Makena (hydroxyprogesterone caproate injection) and eight ANDAs that reference the product. The drug had previouslyreceived accelerated approval to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. When a required confirmatory study did not verify clinical benefit, CDER proposed withdrawing the drug’s approval in 2020\. Covis requested a hearing that was held by the Obstetrics Reproductive and Urologic Drugs Advisory Committee on 10/19/2022\. Following the hearing, at which the panel voted 14-1 to recommend the withdrawal, presiding officer **Celia Witten**, CDER deputy director, recommended that Makena be withdrawn from the market because it does not have a favorable risk/benefit profile. To view the notice, click [here](https://public-inspection.federalregister.gov/2023-10264.pdf?ref=fdaweb.com).