Content about 17-Hydroxyprogesterone caproate

February 27, 2012
FDA declines to approve Watson reproductive drug

The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

January 23, 2012
FDA panel gives thumbs down to Columbia Labs reproductive drug

A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

March 31, 2011
FDA OKs continued compounding of versions of Makena

Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.

February 11, 2011
Makena receives FDA approval

The Food and Drug Administration has approved a drug for preventing preterm births.

January 13, 2011
K-V: FDA will approve Gestiva by PDUFA date

K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

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