Valeant Pharmaceuticals Receives Complete Response Letter

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While much of the investing world was focusing on Valeant Pharmaceuticals' $8.7 billion acquisition of eye-care specialist Bausch & Lomb, the specialty pharmaceutical also reported it has received a complete response letter from the FDA for efinaconazole, its treatment of onychomycosis, a nail fungus.

As Valeant details, a complete response letter is issued by the regulatory agency when its review of a file is completed and questions remain that preclude it from approving the new drug application in its current form. In the case of efinaconazole, Valeant says the concerns raised pertain only to Chemistry, Manufacturing, and Controls (CMC) related to areas of the container closure apparatus and have nothing to do with the drug's efficacy or safety.

As a result, Valeant says it expects to be able to respond to the FDA in a timely manner and will be able to meet the issues raised.


Earlier this month, it had agreed to postpone the launch of efinaconazole until after September, when an arbitration hearing is scheduled to resolve a breach-of-contract dispute with Anacor Pharmaceuticals. Valeant said it intends to vigorously contest Anacor's claims and still expects to launch sometime this year.

The article Valeant Pharmaceuticals Receives Complete Response Letter originally appeared on Fool.com.

Fool contributor Rich Duprey has no position in any stocks mentioned, and neither does The Motley Fool. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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