Depomed neurology news
Depomed said a judge in the U.S. Federal District Court for the District of Columbia ruled that FDA is required to grant Orphan Drug exclusivity to Gralise gabapentin for postherpetic neuralgia (PHN). The exclusivity period will extend until Jan. 28, 2018. In September 2012, Depomed sued FDA claiming the agency violated the Orphan Drug Act by denying Gralise seven years of Orphan exclusivity after the drug's approval in 2011. The company said FDA incorrectly required the demonstration of Gralise's clinical superiority to Neurontin gabapentin, which has the same active ingredient as Gralise but does not have Orphan Drug exclusivity. FDA regulations require the agency to impose additional requirements for Orphan exclusivity only when a product is the same drug as another product that already has Orphan Drug exclusivity. Depomed reported $26 million in Gralise sales for the six months ended June 30. Gralise is a once-daily formulation of gabapentin using Acuform delivery technology (see BioCentury, Oct. 1, 2012). ...