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Brand Names Use Citizen Petitions To Halt Generics

Law360 (October 26, 2006, 12:00 AM EDT) -- Last spring, Roxane Laboratories Inc. was on the verge of getting a generic version of Flonase nasal spray approved by the U.S. Food & Drug Administration. But at the last moment, Flonase’s manufacturer, GlaxoSmithKline, handed the FDA a citizen petition, a tactic that brand name companies have increasingly used to delay the release of generics.

Any person or company can file a citizen petition to take issue with a new generic drug application. However, brand name companies often use them as a last-gasp effort to subdue...
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