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Watson sues US FDA over generic Actos exclusivity denial

This article was originally published in Scrip

Executive Summary

The US FDA has refused to grant shared exclusivity to Watson Pharmaceuticals for its generic version of the Type II diabetes agent pioglitazone – "unnecessarily" delaying the launch of the drug by up to six months, causing "potential harm to consumers who may face constraints on supply as a result of this action," the company is charging in a lawsuit filed against the agency.

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