Taro Pharmaceuticals Announces FDA Approval; Agency Approves ANDA for Clobetasol Propionate Emollient Cream USP, 0.05%

Business Wire, May 18, 2000

Business Editors

HAWTHORNE, N.Y.--(BUSINESS WIRE)--May 18, 2000

Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) today reported that Taro Pharmaceuticals U.S.A., Inc., the Company's U.S. subsidiary, received notification from the U.S. Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Emollient Cream USP, 0.05% ("Clobetasol E Cream").

Taro's Clobetasol E Cream, is a very high potency topical corticosteroid indicated for the treatment of moderate to severe dermatologic conditions. Clobetasol E Cream is bioequivalent to Glaxo Wellcome, Inc.'s Temovate E(R) Cream. The U.S. market for Clobetasol E Cream is estimated by industry sources to be approximately $17 million.

"Taro now provides the full line of generic Clobetasol products," stated Barrie Levitt, M.D., Chairman of the Company. "We already market Clobetasol Propionate Cream, Ointment, Gel and Topical Solution. Clobetasol has been a strong product for us and we look forward to the additional benefits both to Taro and to our customers of being able to offer the full Clobetasol product line."

Sixth Approval in Second Quarter

Clobetasol E Cream is the sixth approval this quarter for Taro. During the second quarter of 2000, Taro received FDA approval for its New Drug Application for Clotrimazole 3-Day Vaginal Cream, its ANDAs for Diflorasone Diacetate Cream, Clorazepate Dipotassium Tablets, Nortriptyline Hydrochloride Capsules, and Clobetasol E Cream, as well as a supplemental ANDA approval for an additional strength of Etodolac Tablets.

Taro currently has multiple international regulatory filings, and eight ANDAs currently submitted to the FDA.

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, please visit the Company's website at http://www.taropharma.com.

To receive additional information on Taro Pharmaceutical Industries, at no charge, dial 1-800-PRO-INFO and enter company code 104 or ticker symbol TARO.

Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurances 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, 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 Annual Report on Form 20-F for the last fiscal year ended December 31, 1998.