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FDA’s Orphan Exclusivity Requirement For “Clinical Superiority” Challenged In Court

 
• By Brenda Sandburg

Depomed argues in a suit against FDA that it should not have to show Gralise (gabapentin) is clinically superior to Neurontin since Neurontin never received an orphan drug designation or orphan exclusivity.

Challenging FDA’s interpretation of the Orphan Drug Act, Depomed Inc. has filed suit against the agency for refusing to grant orphan exclusivity to Gralise (gabapentin) for management of post-herpetic neuralgia, prolonged pain after shingles.

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