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Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)‏


FDA (or the Agency) approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Beginning many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug.
As explained in a November 8, 2011 statement, in October 2011, FDA received information from Makena’s sponsor, K-V Pharmaceuticals, regarding the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone caproate products. The Agency explained that FDA had carefully reviewed the data K-V submitted and would conduct an on-site review of the laboratory analyses. The Agency also stated that FDA had begun its own sampling and analysis of compounded hydroxyprogesterone caproate products and the bulk APIs used to make them.
FDA has completed its review, and the Agency is now providing a brief summary of the results. FDA collected samples of compounded hydroxyprogesterone caproate products and hydroxyprogesterone caproate APIs. These samples generally were collected from compounding pharmacies, doctor’s offices, API distributors, and APIs offered for importation.

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