BioCentury
ARTICLE | Politics & Policy

FDA says Depomed is exception to rule

December 23, 2014 4:11 AM UTC

FDA issued a notification on Monday stating the agency will not change its policy for granting Orphan Drug exclusivity in light of a September federal court ruling in favor of Depomed Inc. (NASDAQ:DEPO) in the company's case against the agency over Gralise gabapentin.

In 2012, Depomed sued FDA after the agency denied Orphan exclusivity to Gralise for the treatment of postherpetic neuralgia (PHN). Depomed claimed FDA violated the Orphan Drug Act when it required the company to demonstrate that Gralise was clinically superior to Neurontin gabapentin. Neurontin contains the same active ingredient as Gralise and was already approved to treat PHN (see BioCentury Extra, Sept. 25, 2012). ...