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FDA May Modify Orphan Exclusivity Reg, But Label Carve-Out Policy Is Intact

 
• By Brenda Sandburg

A district court rejects FDA’s “clinical superiority” requirement for Gralise orphan exclusivity, while another court upholds the agency’s finding that an ANDA label carve-out may overlap partially with a protected method of use.

FDA had a mixed day in court on Sept. 5 as one judge rejected its policy for denying Depomed Inc.’s Gralise orphan drug market exclusivity and another upheld its decision to allow ANDA sponsors to carve out indications for generics even though they may overlap partially with a patented method of use.

The decision in the Depomed case may change how FDA handles requests for orphan drug designations for me-too drugs as the agency could decide to require sponsors to show clinical superiority before granting the designation. Meanwhile, the label carve-out case involving generic versions of Hospira Inc

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