KV Pharma Related ($KV): Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)
An FDA press release just came out about the Makena compounding issue:
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.So, it does not sound like the compounding pharmacies will be prohibited from selling their compounded version that competes with Makena.
FDA has completed its review, and the Agency is now providing a brief summary of the results. [...]
Although the analysis of this limited sample of compounded hydroxyprogesterone caproate products and APIs 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. [...]
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.