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Jul 09, 2012
 |  BC Week In Review  |  Company News  |  Other News

KV Pharmaceutical genitourinary news

KV filed a suit in the U.S. District Court for the District of Columbia alleging that FDA's statements and policy on compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for preterm birth drug Makena hydroxyprogesterone caproate under the Orphan Drug Act of the Food, Drug and Cosmetic 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...

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