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HHSC Has Removed Makena Effective April 7, 2023

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On April 6, 2023, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena. The Texas Health and Human Services Commission (HHSC) has removed the following Makena products and their clinical prior authorization from all formularies as of April 7, 2023:

National Drug Code (NDC)

Drug Name

00517176701

Hydroxyprogesterone caproate/PF

250 mg/ml vial

55150030901

Hydroxyprogesterone caproate/PF

250 mg/ml vial

64011030103

Makena 275 mg/1.1 ml autoinjector

67457096701

Hydroxyprogesterone caproate/PF

250 mg/ml vial

69238179701

Hydroxyprogesterone caproate/PF

250 mg/ml vial

71225010401

Hydroxyprogesterone caproate/PF

1,250 mg/5 ml

71225010501

Hydroxyprogesterone caproate/PF

250 mg/ml vial

Contact vdp-formulary@hhsc.state.tx.us with comments or questions.