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UPDATE: K-V Pharmaceutical Announces Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena and Compounded 17P Formulations


Recent testing conducted by independent laboratories, commissioned by Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company (NYSE: KV.A), shows that multiple samples of both compounded 17P drug formulations and active pharmaceutical ingredient that may be used in compounded 17P failed to meet certain established standards for potency and purity.

These findings, which have been submitted to the U.S. Food and Drug Administration, demonstrate important quality differences in these compounded 17P formulations when compared to FDA-approved Makena® (hydroxyprogesterone caproate injection).

Posted-In: News FDA


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