Valeant Slides as FDA Report Hampers Drug Application

Shares of Valeant Pharmaceuticals (VRX) slipped Friday after a potentially lucrative drug under review failed to pass FDA muster after an inspection of a Tampa-based manufacturing plant. Valeant said Friday that the FDA sent a Complete Response Letter following the submission of Valeant's application for a drug, labeled latanoprostene bunod, that treats glaucoma and hypertension. The FDA cited concerns raised by an inspection of a facility run by the drug's manufacturer, Valeant subsidiary Bausch & Lomb. Valeant was not specific about any particular flags raised, but said the FDA did not identify efficacy or safety concerns related to the drug itself -- just concerns related to the Florida facility -- and noted the company plans to meet with the FDA "as soon as possible" to reach a resolution.

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