Taro Gets Tentative Nod From FDA For Terbinafine Antifungal Cream ...
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(RTTNews) - Taro Pharmaceutical Industries Ltd. (TARO Powerrating), an Israel-based pharmaceutical company, revealed on Thursday that its U.S. affiliate received tentative approval from the U.S. Food and Drug Administration or FDA for its abbreviated new drug application for terbinafine antifungal cream. The company stated that the product was determined by FDA to be more effective and safe than the reference listed drug product, Lamisil.
The company's Terbinafine Hydrochloride Cream 1% or terbinafine cream is an over-the-counter product. The company claims the drug cures athlete's foot, jock itch and ringworm, and in addition, relieves the itching, cracking, burning and scaling that accompany these conditions. The date of expiry of the listed patent of Lamisil cream is December 30, 2006. Taro reported that according to industry sources, Lamisil cream's annual sale in the U.S. is in excess of $45 million.
The company also revealed that it was the first tentative ANDA approval for terbinafine cream received by a company in the U.S. However, the company noted that the tentative approval does not grant marketing rights. A final approval for an ANDA submission is required for marketing a product.
Shares of TARO are trading at $13.70, gaining 16 cents or 1.18%
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