Valeant Pharmaceuticals Receives Complete Response Letter
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.
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