KV sues FDA over Makena

KV Pharmaceutical Co. (NYSE:KV-A) filed suit against FDA in the U.S. District Court for the District of Columbia alleging that the agency's statements and policy of non-enforcement for compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for preterm birth drug Makena hydroxyprogesterone caproate under the Orphan Drug Act. KV also disclosed in the complaint that it will exhaust its capital in three to six months and will need to file for bankruptcy unless FDA publically signals that it will stop the "unlawful competition" by compounded products. At March 31, the company had $50.7 million in cash. The news sent shares of KV sliding $0.15 (23%) to $0.50 on Friday.

The company said FDA's actions give de facto approval to the compounded products, which have been used as a cheaper alternative to Makena, and have "effectively nullified" Makena's seven years of exclusivity. KV is seeking an order that FDA withdraw previous statements on compounded hydroxyprogesterone caproate products. KV also wants FDA to issue a statement declaring that compounded products are illegal and to take "sufficient enforcement actions" to stop their distribution, including preventing the importation of APIs for the compounded products. ...