Depomed sues FDA over Orphan exclusivity for PHN drug

Depomed Inc. (NASDAQ:DEPO) sued FDA in the U.S. District Court for the District of Columbia seeking to force the agency to grant Orphan Drug exclusivity for Gralise gabapentin to manage postherpetic neuralgia. In its complaint, Depomed claimed FDA 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. ...