HAWTHORNE, N.Y., Oct. 13, 2004 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. ("Taro") (Nasdaq:TARO) reported today that Taro Pharmaceuticals U.S.A., Inc. ("Taro USA"), its U.S. affiliate, has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Betamethasone Dipropionate Ointment (Augmented) USP, 0.05%.
The Taro USA product is bioequivalent to Schering-Plough's Diprolene(r) ointment. Augmented betamethasone dipropionate ointment is a prescription topical corticosteroid product used in managing inflammatory skin conditions. According to industry sources, U.S. sales of augmented betamethasone dipropionate ointment products were $7.7 million in 2003.
In December 2003, Taro USA received ANDA approvals for augmented betamethasone dipropionate cream and gel products. Together with this approval, Taro USA will provide a complete line of generic augmented betamethasone dipropionate cream, ointment and gel products.
Ciprofloxacin Tablets
Earlier this month, Taro received final approval for its ANDA for ciprofloxacin tablets USP in 250, 500 and 750 mg strengths, bioequivalent to Bayer's Cipro(r) tablets in the same strengths, and a tentative ANDA approval for the 100 mg strength.
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.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's augmented betamethasone dipropionate and ciprofloxacin products. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's augmented betamethasone dipropionate or ciprofloxacin products; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its 2003 Annual Report on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.