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FDA prevails in suit on exclusivity loss for generic Cozaar by Teva

This article was originally published in Scrip

Executive Summary

Teva Pharmaceutical Industries has suffered a setback in its efforts to challenge the US FDA's "delisting rule" as it relates to its loss of first-filer marketing exclusivity on generic versions of Merck & Co's Cozaar (losartan potassium) and Hyzaar (losartan plus hydrochlorothiazide). A US judge has ruled that judgement would be in the FDA's favour.

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