Taro Pharmaceutical Industries Ltd has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Econazole Nitrate Cream 1% (Econazole Cream).
Taro's Econazole Cream is bioequivalent to Ortho-McNeil Pharmaceutical's Spectazole Cream. This prescription pharmaceutical is used primarily in treating fungal infections of the skin. Taro believes it has the first U.S. approval to manufacture and market a generic equivalent to Spectazole.
According to industry sources, U.S. sales of Spectazole Cream were approximately $54 million in 2001. Taro is a leader in the U.S. markets for topical corticosteroids and antifungal medications, including both prescription and over-the-counter drugs.
"This approval again demonstrates Taro's ability to conduct the extensive clinical studies required by the FDA for approval of topical antifungal products," said Barrie Levitt, Chairman of the Company.
Taro currently has 17 ANDAs on file with the U.S. Food and Drug Administration, including one tentative approval. In addition, the Company has multiple regulatory filings in Canada, Israel and other countries around the world.