AMAG Pharmaceuticals’ Abbreviated NDA for Progestin Injection Receives FDA Approval

AMAG Pharmaceuticals (AMAG) disclosed in a regulatory filing late Monday that the U.S. Food & Drug Administration (FDA) has approved the the abbreviated new drug application for Hydroxyprogesterone Caproate Injection USP, 250 mg/mL (1.25 g/5 mL vials).

The NDA was initially submitted by McGuff Pharmaceuticals, Inc. in 2009.

AMAg also said it has obtained, through a Freedom of Information Act request, the package insert for this product.

Hydroxyprogesterone Caproate is a man-made hormone of progestin. It is used in pregnant women to help lower the risk of giving birth too early (preterm birth or giving birth less than 37 weeks of pregnancy).

Shares are up 0.02% at $41.35 in the after hours session, with a 52-week range of $29.76 – $77.73.

Companies: AMAG Pharmaceuticals, Inc.
Price: 41.35 Price Change: +0.01 Percent Change: +0.02

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