Valeant Pharmaceuticals Receives Complete Response Letter

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While much of the investing world was focusing on Valeant Pharmaceuticals' (NYSE: VRX  ) $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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Rich Duprey

Rich has been a Fool since 1998 and writing for the site since 2004. After 20 years of patrolling the mean streets of suburbia, he hung up his badge and gun to take up a pen full time.

Having made the streets safe for Truth, Justice and Krispy Kreme donuts, he now patrols the markets looking for companies he can lock up as long-term holdings in a portfolio. So follow me on Facebook and Twitter for the most important industry news in retail and consumer products and other great stories.


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5/24/2016 9:31 AM
VRX $26.48 Up +0.27 +1.03%
Valeant Pharmaceut… CAPS Rating: ***