Reuters: Regulatory News: Valeant says FDA denies approval to nail infection drug

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Valeant says FDA denies approval to nail infection drug May 28th 2013, 11:45 Tue May 28, 2013 7:45am EDT May 28 (Reuters) - Canada drugmaker Valeant Pharmaceuticals International said on Tuesday that the U.S. Food and Drug Administration denied approval for its drug to treat onychomycosis, a fungal infection of the nail. The U.S. health regulator raised questions about manufacturing and controls related to the drug's container in a complete response letter to the company. Valeant said the FDA did not raise any questions regarding the efficacy or safety of the drug efinaconazole. The company said it was working on a timely response to the FDA. Onychomycosis causes nails to deform, discolor, thicken, become brittle and split and separate from the nail bed. Quebec-based Valeant said on Monday it would buy Bausch & Lomb Holdings Inc from Warburg Pincus LLC for $8.7 billion, a deal set to vault the Canadian company into the upper ranks of the global pharmaceutical sector.

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