Business Wire - Taro Pharmaceuticals Announces FDA Approval; Agency Approves ANDA for Carbamazepine Oral Suspension
Business Editors & Health/Medical Writers
HAWTHORNE, N.Y.–(BUSINESS WIRE)–Oct. 25, 2000
Taro Pharmaceutical Industries Ltd. (NASDAQ/NMS:TARO) today reported that the Company has received notification from the U.S. Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP (Chewable), 100mg (”Carbamazepine Chewable”).
Carbamazepine Chewable is an anticonvulsant used in the treatment of epilepsy and other seizure disorders. The chewable dosage form is used primarily in the pediatric setting. Taro’s Carbamazepine Chewable is bioequivalent to Novartis’ Tegretol(R) Chewable Tablets. The U.S. market for Carbamazepine Chewable is estimated by industry sources to be $18 million.
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“Taro has manufactured and marketed carbamazepine products for over thirty years,” stated Barrie Levitt, M.D., Chairman of the Company. “Carbamazepine Chewable is an extension to a product line in which Taro has both expertise and experience.”
Vertical Integration
Taro synthesizes the active ingredient used in all of its carbamazepine products. This vertical integration ensures a reliable, high quality source of supply, as well as enhanced profitability.
Taro currently has multiple international regulatory filings, and ten 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.taro.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, 1999.
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