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FDA Reviewing Quality of Compounded 17P and its Active Pharmaceutical Ingredients

On November 8, the U.S. Food and Drug Administration (FDA) issued a statement that it has begun its own sampling and analysis of compounded hydroxyprogesterone caproate products and the bulk active pharmaceutical ingredients (APIs) used to make them. The investigation was prompted by information the FDA received from K-V Pharmaceutical regarding independent laboratory testing the Company performed demonstrating important quality differences between FDA-approved Makena and compounded 17P formulations. The testing specifically showed multiple samples of both compounded 17P drug formulations and API that may be used in compounded 17P failed to meet certain established standards for potency and purity.

FDA noted in its statement, that the agency “reminds healthcare providers and patients that before approving the Makena new drug application, FDA reviewed manufacturing information, such as the source of the API used by the manufacturer, proposed manufacturing processes and the firm’s adherence to current good manufacturing practice. Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product.”

To read the complete FDA statement, visit the FDA’s website. For more details regarding K-V Pharmaceutical Company’s independent laboratory testing of 17P, visit the company’s website at www.kvpharmaceutical.com, or to learn more about Makena, please visit www.makena.com.