Valeant says FDA denies approval to nail infection drug

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Valeant says FDA denies approval to nail infection drug

(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. ...

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