Taro Receives FDA Approval for Clotrimazole and Betamethasone Dipropionate Lotion ANDA; Generic Equivalent to Lotrisone Lotion.

HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) reported today that its U.S. affiliate has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for clotrimazole and betamethasone dipropionate lotion ("C/B lotion").

Taro's C/B lotion is bioequivalent to Schering's Lotrisone(R) lotion. C/B lotion is a combination topical corticosteroid and antifungal product available by prescription only. It is used to treat inflammatory fungal infections of the skin, including athlete's foot. According to industry sources, U.S. sales of Lotrisone(R) lotion were approximately $39 million in 2003.

Currently, Taro has 31 filings at the FDA: 30 ANDAs, including tentative approvals for fluconazole tablets and loratadine syrup, plus one New Drug Application related to the Company's NonSpil(TM) liquid drug delivery system. In addition, the Company has multiple regulatory filings in Canada, Israel and other countries.

Taro 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 ...