FDA approves aingle dose formulation of Makena (hydroxyprogesterone caproate injection) for preterm labour -AMAG Pharmaceuticals

The FDA has approved a single-dose, preservative-free formulation of Makena (hydroxyprogesterone caproate injection) from AMAG Pharmaceuticals. Makena is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past. The single-dose formulation is an expansion of the Makena product line. Packaged in trays of four (a month’s supply), the single-dose formulation provides an alternative package size to the current multi-dose vial, which contains five weekly injections. AMAG currently expects to commercialize the new single-dose, preservative-free formulation of Makena in the second quarter of 2016.

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.