KV gains after FDA issues Makena Q&A

KV Pharmaceutical Co. (NYSE:KVA) gained $0.08 (15%) to $0.62 on Monday after FDA issued a Q&A clarifying a June 15 statement in which the agency said it found no major safety problems in an analysis of compounded hydroxyprogesterone caproate products, which have been used as a cheaper alternative for KV's preterm birth drug Makena hydroxyprogesterone. The agency said, "if there is an FDA-approved drug that is medically appropriate for a patient, the FDA-approved product should be prescribed and used." FDA also reiterated that it may take enforcement action against compounding pharmacies, if warranted (see BioCentury Extra, June 18).

FDA approved Makena in February 2011 to reduce the risk of preterm birth in pregnant women with a history of at least one spontaneous preterm birth. In March 2011, the agency said it would not prevent compounding pharmacies from selling competing products. KV subsequently cut the drug's list price to $690 per injection from $1,500. Prior to approval of Makena, a compounded version was available from compounding pharmacies for $10-$20 a dose. ...