FDA Issues Further Guidance About Makena®

K-V Pharmaceutical Company (NYSE: KV.A) today addressed the additional guidance provided by the U.S. Food and Drug Administration (FDA), which issued a Questions and Answers document on June 29 to clarify its June 15, 2012 statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena®). FDA provides further guidance to healthcare providers and pregnant women at high risk for recurrent preterm birth, recommending the use of FDA-approved Makena® rather than compounded drug formulations of hydroxyprogesterone caproate.

The agency also describes its enforcement policy towards compounded formulations of hydroxyprogesterone caproate. Makena® is the only FDA-approved medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

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