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Indication 'Carve In' Allowed Under Generic Labeling 'Carve-Out' Authority, US FDA Says

 
• By Sue Sutter

In citizen petition response involving Takeda's Velcade, agency says ANDA and 505(b)(2) applicants may add more words to the indication statement in order to carve-out protected uses from the reference product's broadly written indication.

Carving a turkey
FDA carves up some succulent labeling.

The US FDA appears to have established a new "carve in" approach to "carving out" a reference product's protected uses from generic drug labeling in its recent response to a Takeda Oncology citizen petition on Velcade (bortezomib).

Velcade is currently indicated for treatment of patients with multiple myeloma and mantle cell lymphoma. These indications have been broadened...

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