FDA's View On Generic Drug Label Carve-Outs

Law360, New York (October 2, 2008, 12:00 AM EDT) -- The Camptosar 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-drug applicant as a result of patent or statutory exclusivity bars.

The U.S. Food and Drug Administration’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...
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