MENLO PARK, Calif. — A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.
Depomed announced that it had filed suit against the FDA in federal district court for the District of Columbia seeking an order that would require the agency to grant the drug Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia. The disease, also known as PHN, is a condition causing prolonged pain in people who have had shingles, a complication of chickenpox.
The FDA granted Gralise orphan drug designation for management of PHN in November 2010 and approved the drug in January 2011, but it has not granted it orphan drug exclusivity. Under FDA regulations, orphan drug designation is given to drugs for diseases that affect fewer than 200,000 people in the United States, and drugs that receive the designation are entitled to seven years' market exclusivity, as opposed to the five years given to other drugs.