FDA Tells DC Circ. KV Drug Compounding Wasn't A Priority
By Erica Teichert
Law360, Washington (May 15, 2013, 4:06 PM EDT) -- The U.S. Food and Drug Administration told the D.C. Circuit on Monday that it acted fully in its discretion when it determined cracking down on competition for bankrupt drugmaker KV Pharmaceutical Co.'s prenatal medicine Makena was not a priority, and asked the court to stay out of the dispute.
Although KV received orphan drug approval for Makena in early 2011, making it the only FDA-backed drug for prevention of premature birth, the FDA has declined to prosecute compounding pharmacies that have continued to market much cheaper...