A Message from NCTracks on Behalf of NC Medicaid Makena End of Coverage and Removal from NC Medicaid Preferred Drug List (PDL)

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.

Per the FDA, approvals of these drugs were withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved. The full press release from the FDA can be found here.

Makena and its generics as well as Compounded 17P are no longer covered at point-of-sale or in the Physician Administered Drug Program, effective 4/7/2023. The latest revision of the PDL reflects this removal.

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