AMAG Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) subcutaneous (SC) auto-injector as a ready-to-use treatment to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

“This drug-device combination product, which features a smaller, non-visible needle, was designed to address some of the known barriers to treatment of recurrent preterm birth, including lack of patient acceptance and adherence,” said Julie Krop, MD, CMO and EVP of clinical development and regulatory affairs at AMAG. 

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Makena is also available as 250mg/mL strength vials for deep intramuscular (IM) injection. The SC auto-injector is anticipated to launch in the second half of March. The IM formulation will continue to be available in single- and multi-dose vials. 

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