Taro 2002 News Archive

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6/27/2002

Taro Receives Tentative Approval for Loratadine Syrup

Hawthorne, NY, June 27, 2002 – Taro Pharmaceutical Industries Ltd. (NASDAQ/NMS: TARO) reported today that the Company has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Loratadine Syrup 10 mg/10 mL.

Taro’s Loratadine Syrup 10 mg/10 mL is a generic version of Schering-Plough’s antihistamine drug, Claritin® Syrup. According to industry sources, the annual market for Loratadine Syrup is estimated to be approximately $70 million.

A tentative approval is an FDA determination that an ANDA submission currently satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed exclusivities and restrictions. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.Patent Challenge

Taro and other pharmaceutical companies are currently involved in litigation with Schering-Plough regarding certain patents held by Schering-Plough for Loratadine. Another generic competitor has the right to an exclusive marketing period for the product, after which Taro, as well as multiple other competitors, expect to receive final approval from the FDA to market Loratadine Syrup.

Taro currently has 14 filings submitted to the FDA, including this tentative approval, and multiple international filings with regulatory agencies 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.

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 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, results of patent challenge litigation, timing of exclusivity periods, 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 year ended December 31, 2001.