Makena End of Coverage and Removal from NC Medicaid Preferred Drug List

FDA approvals of these drugs were withdrawn.

On April 6, 2023, the Food and Drug Administration (FDA) announced that Makena® (hydroxyprogesterone caproate injection) and generics for Makena® are no longer FDA-approved.

FDA approvals of these drugs were withdrawn because they are no longer demonstrated to be effective, and the benefits do not outweigh the risks of use(s) for which they were approved. For more information, refer to the FDA news release FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena.

Makena and its generics, as well as Compounded 17P, are no longer covered at point-of-sale effective April 7, 2023. The PDL April 1, 2023 Revised 4.28.2023 version of the Preferred Drug List reflects this removal. 

Beneficiaries who have questions are encouraged to speak with their healthcare provider for further guidance.


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