AMAG Pharmaceuticals announces FDA approval of New Single-Dose, Preservative-Free Makena®
AMAG Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the company’s single-dose, preservative-free formulation of Makena® (hydroxyprogesterone caproate injection). 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.
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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.
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AMAG currently expects to commercialize the new single-dose, preservative-free formulation of Makena in the second quarter of 2016.