Taro receives tentative OK for terbinafine cream, generic equivalent to Lamisil

By Elaine Rigoli

Tampa, Fla., March 23 - Taro Pharmaceutical Industries Ltd. reported Thursday that its U.S. affiliate has received tentative approval from the 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., according to a company news release.

Terbinafine cream is an over-the-counter antifungal product that cures most athlete's foot, jock itch and ringworm, and relieves the itching, cracking, burning and scaling which accompany these conditions, the release said.

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

The listed patent on Lamisil expires Dec. 30, 2006, the release said.

Taro is a multinational, science-based pharmaceutical company with U.S. headquarters in Hawthorne, N.Y.

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