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FDA And CMS Issue Important Updates On Makena®

ST. LOUIS, June 18, 2012 /PRNewswire/ -- K-V Pharmaceutical Company ("the Company") (NYSE: KV.A/KV.B) announced today that the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) both issued updated statements on Makena® that affirm the importance of the only FDA-approved drug for treatment of women with a history of preterm birth.  Prior statements by both agencies had been cited by some payers as the basis for denying patients' access to FDA-approved Makena in favor of unapproved compounded hydroxyprogesterone caproate (17P) formulations. 

FDA's June 15, 2012 update highlights:

  • In a reversal of its March 30, 2011 statement, the "FDA emphasizes that it is applying its normal enforcement policies for compounded drugs to compounded hydroxyprogesterone caproate."
  • "The compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding."
  • "Compounding large volumes of drugs that are copies of FDA-approved drugs circumvents important public health requirements, including the Federal Food, Drug, and Cosmetic Act's drug approval provisions."
  • "…one factor that the agency considers in determining whether a drug may be compounded is whether the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product."
  • "The drugs that pharmacists compound (including compounded hydroxyprogesterone caproate) are not FDA approved, which means they do not undergo premarket review nor do they have an FDA finding of safety and efficacy."
  • For at least the third time in the past 15 months, FDA has reiterated that "…approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products."

For more information about FDA and Pharmacy Compounding, please see the following links:

FDA's statement also summarized the results of its investigation of a limited number of samples of compounded hydroxyprogesterone caproate API and finished 17P, including the following:

  • 100% (16 of 16) of the API samples procured and tested by FDA failed Makena's standards for unidentified impurities.  According to FDA requirements, API of this quality is unsuitable for use in Makena®. 
  • FDA also found potency and unidentified impurity issues in compounded 17P finished goods samples.  According to FDA requirements, if Makena® were to have these deficiencies, it would be considered adulterated. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070287.pdf
  • FDA's testing of the compounded 17P samples provided by the Company also confirmed variability in potency and purity.

In addition, the Company's previously reported research found: 

  • That the primary source of hydroxyprogesterone caproate is unregistered and/or uninspected manufacturing facilities in China
  • That one of seven samples of API from the original Chinese manufacturers was not hydroxyprogesterone caproate, but was instead glucose

More recently, the Company has identified and provided information to the FDA relating to multiple instances of intentionally mislabeled hydroxyprogesterone caproate API sourced from multiple Chinese suppliers. 

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