Valeant gets drug, contact-lens approvals, shares rise

Thu Oct 3, 2013 11:17am EDT
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By Rod Nickel

Oct 3 (Reuters) - Canadian drugmaker Valeant Pharmaceuticals Inc won regulatory approval on Thursday for a topical nail fungus drug in Canada and clearance for a new contact lens in the United States, pushing its shares up nearly 2 percent.

Health Canada approved Valeant's Jublia, a topical solution that uses the drug efinaconazole to treat onychomycosis, a nail infection caused by fungi.

Other approved topical treatments have limited effectiveness, and oral treatments are limited by interactions with other drugs and safety concerns, Valeant said.

Jublia is the first new approved topical treatment for the infection in more than a decade, it said.

Valeant also said the U.S. Food and Drug Administration (FDA) had cleared Bausch + Lomb's latest frequent replacement contact lens.

Both approvals are positive developments for Valeant, which agreed in May to acquire Bausch + Lomb, said Morningstar analyst David Krempa.

"If efinaconazole gets U.S. approval, that would be a bigger deal since the U.S. market is about 10 times Canada," he said.

The FDA denied approval for the drug in May, raising questions about manufacturing and controls related to the drug's container. Valeant said it was working on a response.   Continued...