Taro Receives Final Approval for Terbinafine HCL Cream 1% ANDA Tuesday July 3, 7:00 am ET Generic Equivalent to Lamisil(R) Cream
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Taro Pharmaceutical Industries Ltd. ("Taro," PINK SHEETS: TAROF) reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Terbinafine Hydrochloride Cream 1% ("terbinafine cream"). Taro had received tentative approval for this ANDA in March 2006.
Taro's terbinafine cream is bioequivalent to Lamisil® Cream of Novartis Consumer Health Inc. Terbinafine cream is an over-the-counter antifungal product which cures most athlete's foot, jock itch and ringworm, and relieves itching, cracking, burning and scaling which accompany these conditions. According to industry sources, Lamisil® Cream has annual U.S. sales in excess of $50 million.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at www.taro.com.
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