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FDA questions preclude approval of GSK/Valeant's anti-epileptic Potiga

This article was originally published in Scrip

Executive Summary

GlaxoSmithKline and Valeant Pharmaceuticals have taken another hit in their bid to gain USFDA approval for their anti-epileptic Potiga (ezogabine), as the companies said the regulator had provided a complete response letter and declined to approve the NDA for the product in its current form for unspecified "non-clinical" reasons.

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