Amag Pharmaceuticals says intends to launch generic version of Makena in U.S.

In a regulatory filing, AMAG Pharmaceuticals announced that it intends to launch an authorized generic version of the single-dose intramuscular formulation of Makena into the U.S. market, through its generic partner, Prasco Laboratories. The company had previously entered into an agreement with Prasco so that it would be prepared to launch its own authorized generic upon the first entry of a generic Makena product, which AMAG now believes is forthcoming given the recent approval by the U.S. Food and Drug Administration of one generic version of the single-dose intramuscular form. Prasco has product inventory available and will commence contracting and shipping product as soon as authorized by AMAG upon launch of a generic product. A mid-year approval and launch of a generic was anticipated in the company’s 2018 revenue, operating loss and non-GAAP adjusted EBITDA guidance previously disclosed in May 2018. As a result of this partnership, AMAG will be able to provide patients and healthcare providers with access to a therapeutically equivalent version of the branded Makena intramuscular injection. AMAG also recently launched a Makena subcutaneous auto-injector. The prefilled Makena auto-injector offers an alternative administration option for patients and providers and contains a shorter, thinner non-visible needle compared to the intramuscular Makena injection. Based on the most recent weekly data, approximately 60% of all new patient enrollments through the Makena Care Connection have been for the Makena subcutaneous auto-injector. Makena and its authorized generic version are indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.

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