K-V: FDA will approve Gestiva by PDUFA date

ST. LOUIS — 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.

K-V, which acquired the injected drug Gestiva (hydroxyprogesterone caproate) from Hologic in 2008, said Hologic originally had been told the FDA would take action Thursday.

K-V said it was confident the drug would receive approval and that the FDA would take action on or before the new PDUFA date.

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