K-V Pharmaceutical Company announced today that the FDA and the Centers for Medicare & Medicaid Services (CMS) both issued updated statements on Makena (hydroxyprogesterone caproate injection; Ther-Rx Corporation) that affirm the importance of the only FDA-approved drug for treatment of women with a history of preterm birth. 

Many years before Makena was approved in February 2011, a version of the active ingredient had been available to patients whose physicians requested the drug from a compounding pharmacist. In October 2011, the FDA received information regarding the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone caproate products. The FDA collected samples from compounding pharmacies, doctor’s offices, API distributors, and APs offered for importation for further analyses.

Upon review, tests found that three of 26 samples failed the standard for potency (90–110%), and seven of 26 samples failed the standard for unidentified impurities using the method in the Makena NDA. Although the analysis of this limited sample did not identify any major safety problems, approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products. The FDA is emphasizing that the compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding.

Makena is a synthetic progestin indicated to reduce risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. It is not intended for use in patients with multiple gestations or other risk factors for preterm birth.

For more information visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm.