Endo urges stricter criteria for approving generic Lidoderm

03/13/2012 | American City Business Journals

Endo Pharmaceuticals Holdings submitted an amended petition asking the FDA to impose tougher approval standards on any generic formulation of painkiller Lidoderm. "Since we filed the original citizen petition in 2006, new studies and opinions from research scientists, as well as public statements from FDA officials, have further validated the need for comparative clinical-endpoint studies to ensure a locally acting topical medication is bioequivalent to the branded product," said Ivan Gergel, Endo's chief scientific officer and executive vice president.

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