AMAG Pharmaceuticals has announced that it has submitted supplemental new drug application (sNDA) to the US FDA for the Makena® subcutaneous auto-injector, a drug-device combination product.
The current Makena intramuscular (IM) injection is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women. Patients receiving Makena® should inform the healthcare provider whether they are allergic to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena.