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news.AMAG Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its single-dose, preservative-free formulation of Makena (hydroxyprogesterone caproate injection) for pregnant women.
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Makena is indicated to lower the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby earlier.
The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation.
The single-dose formulation is an expansion of the Makena product line. Currently, it is packaged in trays of four, a month’s supply, offering an alternative package size to the already-available multi-dose vial, which has five weekly injections.
The new formulation offers the flexibility of a single-use vial for once-weekly dosing, eliminating the need to store a multi-dose vial.
Pharmacists can dispense a month’s supply of single-dose Makena vials or dispense individual single-dose vials for women who come close to their course of therapy, AMAG said.
The company plans to commercialize the new single-dose, preservative-free formulation of Makena in the second quarter of this year.
AMAG Pharmaceuticals CEO William Heiden said: "We believe the single-dose formulation is an important first step in our next generation development program for Makena and further demonstrates the company’s dedication to improving the quality of care for women at risk of preterm birth."