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Drug Approval Standards Generic Drugs Regulation

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

  • Analysis

Executive Summary

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.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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