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FDA Grants Gralise Orphan Exclusivity But Rejects Policy Change

 
• By Brenda Sandburg

FDA bows to a court ruling requiring it to award orphan drug market exclusivity to Depomed’s gabapentin, but the agency says it will continue to require the sponsor of a drug that is the “same” as a previously approved drug to show that it is “clinically superior” in order to be eligible.

FDA opted not to fight a court order requiring it to award Depomed Inc.’s Gralise (gabapentin) seven years of orphan drug market exclusivity. But the agency is not changing its policy on orphan exclusivity: a sponsor will still have to show its product is clinically superior to the same previously approved drug in order to win the designation.

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