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Article: FDA Confirms Its View On Generic Drug Label Carve-Outs.(Food and Drug Administration)(Drug Price Competition and Patent Term Restoration Act of 1984)
- Article from:
- Mondaq Business Briefing
- Article date:
- September 2, 2008
CopyrightCOPYRIGHT 2008 Mondaq Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The Camptosar[R] decision clarifies questions surrounding whether and to what extent a generic drug applicant must match each of the pioneer drug's labeled uses or whether certain uses of the pioneer drug can be carved out by the generic applicant as a result of patent or statutory exclusivity bars.
The U.S. Food and Drug Administration's (FDA's) approach to generic drug applications that seek approval for one or more, but not all, of the uses of a brand name "pioneer" drug has been evolving over time.
Generic drug makers sometimes seek "carve-outs" because of concerns about patent or statutory exclusivity rights that protect the carved-out ...