Pharmacy services provider PharMerica Corp. is questioning claims made recently by KV Pharmaceutical ($KV.A) that the latter's FDA-approved premature-birth prevention drug Makena provides greater consistency than the long-standing compounded treatment. KV has presented the FDA with data that it claims show variability in the purity and potency of the compounded progesterone injection.
As a result, the FDA said it is conducting an analysis of its own. KV has not made public the data it recently submitted to the FDA.
PharMerica said in a statement it contacted KV to find out whether any of the "purportedly questionable samples" of compounded hydroxyprogesterone used in its analysis came from PharMerica. KV, which said it tested the compounded treatment and samples of the bulk hydroxyprogesterone caproate (17P) API against Makena, refused to provide details.
The service provider said in the statement that it's confident the compounded 17P it provides meets FDA safety requirements.
After gaining approval for Makena in February, KV sent a letter to pharmacies implying the FDA may take regulatory action against pharmacies that continued compounding hydroxyprogesterone.
The FDA responded by announcing it intended to take no such action, despite making an earlier statement that "greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product."
- here's the announcement