Taro Gets Tentative OK on Generic Lamisil

HAWTHORNE, N.Y. — Israel-based drug maker Taro Pharmaceutical Industries Ltd. said Thursday it received tentative approval from the Food and Drug Administration for a generic version of Novartis AG's antifungal cream Lamisil.

The action covers over-the-counter terbinafine hydrochloride cream 1 percent, the active ingredient in Lamisil.

The FDA grants tentative approvals when the brand name drug is still protected by patents or exclusive selling rights. The patent for over-the-counter Lamisil expires Dec. 30. Taro believes that it was the first to file an application for a generic version of the product, which would give the company 180 days of market exclusivity when fully approved.

Lamisil cream has annual sales of more than $45 million, the company said.

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