FDA Oks Valeant toenail fungus treatment Jublia

The Food and Drug Administration has approved a toenail fungus treatment from Valeant Pharmaceuticals International Inc. that could reach $800 million in peak U.S. sales, according to the Canadian drugmaker.

Valeant plans to launch the topical treatment, Jublia, in the third quarter in the United States.

Jublia treats onychomycosis, a nail infection caused by a fungus that typically occurs under the toenail but also can affect fingernails. About 35 million Americans have the condition, with most being men between the ages of 50 and 70.

Valeant acquired the drug with its 2008 purchase of Dow Pharmaceutical Sciences. It then agreed last fall to pay Anacor Pharmaceuticals Inc. $142.5 million to settle a dispute involving a contract between Anacor and Dow regarding Jublia.

Separately, Valeant is teaming with activist investor Bill Ackman in a bid to buy Botox-maker Allergan. They made an unsolicited bid of about $45.6 billion in April, and their latest offer amounts to $53 billion in cash and Valeant stock.

U.S.-traded shares of Valeant closed at $127.46 on Friday and have climbed more than 8 percent so far this year.