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Taro Receives Marketing Authorization in UK for Etopan XL Tablets 600 mg, Etodolac |
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14 Nov 2006 |
Company Also Receives UK Approval for Tarodent Mouthwash
HAWTHORNE, NY, USA | Nov 13, 2006 | Taro Pharmaceutical Industries Ltd. ("Taro," NASDAQ: TARO) reported today that Taro Pharmaceuticals (UK) Limited ("Taro UK"), its affiliate in the United Kingdom, has been granted a marketing authorization for Etopan XL Tablets 600 mg, Etodolac ("Etopan XL") by the Medicines and Healthcare Products Regulatory Agency, the UK equivalent of the U.S. Food and Drug Administration.
Etopan XL, a prescription product, is the first approved UK generic alternative to Lodine(TM) SR Tablets 600 mg, which is marketed in the UK by Shire Pharmaceuticals. Etopan XL is a non-steroidal anti-inflammatory drug taken for acute or long-term use in rheumatoid arthritis and osteoarthritis. According to industry sources, Lodine(TM) SR Tablets have annual sales of approximately US$18 million in the UK.
"The introduction of Etopan XL represents a significant addition to our product portfolio in the UK," said Samuel Rubinstein, Senior Vice President and General Manager of Taro and the head of Taro's European operations.
Tarodent Marketing Authorization in the UK
Taro UK has also been granted a marketing authorization by the Medicines and Healthcare Products Regulatory Agency for Tarodent 0.2% Mouthwash, 0.2% w/v chlorhexidine digluconate ("Tarodent Mouthwash"). Tarodent Mouthwash, an over-the-counter product, is a generic alternative to Corsodyl Mouthwash, which is marketed in the UK by GlaxoSmithKline Consumer Healthcare. Tarodent Mouthwash is used for the treatment and prevention of gingivitis, maintenance of oral hygiene and treatment of oral thrush and mouth ulcers.
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, 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 new Etopan XL and Tarodent Mouthwash products in the UK. 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; marketplace acceptance of the new Taro 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 Annual Reports 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.
CONTACT: Taro Pharmaceutical Industries Ltd.
Daniel Saks, 914-345-9000 ext. 6208
Vice President, Corporate Affairs
or
Zahava Rafalowicz, 011-972-9-9711824
Group Vice President, Sales and Marketing
SOURCE: Taro Pharmaceutical Industries Ltd. |
