HAWTHORNE, N.Y., Dec 9, 2003 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (NASDAQ: TARO) reported today that its U.S. affiliate has received approvals from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Applications ("ANDAs") for betamethasone dipropionate cream (augmented), 0.05% and betamethasone dipropionate gel (augmented), 0.05%.

The Taro products are bioequivalent to Schering-Plough's Diprolene(R) AF cream and Diprolene(R) gel. Augmented betamethasone dipropionate cream and gel are prescription topical corticosteroid products used primarily in managing inflammatory skin conditions. As with the bioequivalent Diprolene(R) products, the vehicles of the Taro cream and gel products augment the penetration of the active ingredient into the skin.

According to industry sources, Diprolene(R) AF cream and Diprolene(R) gel had 12-month U.S. sales of approximately $54 million and $6 million, respectively, through the third quarter of 2003.

"These products offer physicians and patients high quality generic alternatives when augmented formulations of betamethasone dipropionate are indicated," said Barrie Levitt, M.D., Chairman of the Company.

Currently, Taro has 32 filings at the FDA: 31 ANDAs, which include two tentative approvals and two unique supplemental ANDAs, plus a 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 around the world.

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 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 introduction of the Company's augmented betamethasone dipropionate 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 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 2002 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.

SOURCE: Taro Pharmaceutical Industries Ltd.

Taro Pharmaceutical Industries Ltd.
c/o Taro Pharmaceuticals U.S.A., Inc.
Daniel Saks, 914/345-9000 ext. 6208
Kevin Connelly, 914/345-9000 ext. 6338