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Expert Analysis

Precedex Decision Will Impact FDA's Use Code System

Law360, New York (September 5, 2014, 10:58 AM EDT) -- The U.S. Food and Drug Administration's Aug. 18, 2014, decision[1] to accept Section VIII certifications for generic versions of Precedex, despite overlap between the labeled uses for these generic versions and the patent use code assigned to Precedex, has significant implications for generic and brand drug manufacturers and calls into question the FDA's administration of patent safeguards under the Hatch Waxman Act.[2]...

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