Depomed Says It Was Cheated Out Of Orphan Drug Exclusivity
By Erica Teichert
Law360, Washington (August 23, 2013, 5:50 PM ET) -- Depomed Inc. urged a Washington federal judge Friday to force the U.S. Food and Drug Administration to give the company seven years of drug exclusivity for its pain drug Gralise, claiming the agency went beyond its authority and added new limitations to its orphan drug program.
According to the drugmaker, the FDA inappropriately determined that Depomed had to show Gralise was clinically superior to other drugs already approved to treat post-herpetic neuralgia, pain stemming from a rash associated with shingles. However, Depomed maintained Congress never gave...