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FDA Weighs Next Move After Appellate Court Rebuffs Patent Delisting Policy

This article was originally published in The Tan Sheet

Executive Summary

FDA is assessing its next step following an appeals court ruling confirming that the agency's position on delisting patents is inconsistent with Hatch/Waxman

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Teva acquires Ivax

Teva has completed the acquisition of generics firm Ivax Jan. 26, the Israeli firm announces in a same-day release. The deal increases Teva's OTC distribution and private label OTC portfolio (1"The Tan Sheet" Aug. 1, 2005, p. 11). To preserve competition, FTC requires that Teva divest all of the rights and assets related to 15 of the firms' prescription generics. The rights and assets to be divested will be divided between Barr Pharmaceuticals and Par Pharmaceuticals. Teva and Ivax are required to provide transitional services to Barr and Par until the firms receive FDA approval to manufacture the drugs themselves. The order will be open to public comment until Feb. 21, 2006. FTC will decide whether to make the order final following the close of the public comment period...

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