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Taro Gets Tentative Approval From FDA For Terbinafine ...

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(RTTNews) - Taro Pharmaceutical Industries Ltd. (TARO Powerrating) reported that its U.S. affiliate has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Terbinafine Hydrochloride Cream 1%.

The FDA has determined that Taro's terbinafine cream is safe and effective for use when compared with the reference listed drug product, Lamisil Cream of Novartis Consumer Health Inc. (NVS Powerrating)

According to industry sources, Lamisil Cream has annual U.S. sales in excess of $45 million.

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