Taro Pharmaceuticals Announces FDA Approvals; Agency Approves ANDA for All Three Strengths of Clorazepate Dipotassium Tablets.Business Editors & Health Writers HAWTHORNE, N.Y.--(BUSINESS WIRE)--April 28, 2000 Supplemental ANDA ANDA abbr. abbreviated new drug application Approval for Etodolac etodolac /eto·do·lac/ (e-to-do´lak) a nonsteroidal antiinflammatory drug used as an analgesic and antiinflammatory, especially to treat arthritis. e·to·do·lac n. Tablets, 500 mg Taro Pharmaceutical Industries Ltd. (NASDAQ/NMS:TARO) today reported that the Company received notification from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approving its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA) for Clorazepate Dipotassium clorazepate dipotassium (klor´  zepāt´ dī´p Tablets USP USP - unique sales point , 3.75 mg, 7.5 mg and 15 mg, and a supplemental ANDA approval for Etodolac Tablets, 500 mg. Clorazepate Dipotassium Latest Vertically Integrated Product Clorazepate Dipotassium Tablets are indicated for the management of anxiety disorders and are bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to Abbott Laboratories' Tranxene(R). The US market for Clorazepate Dipotassium Tablets is estimated by industry sources to be approximately $100 million. "Clorazepate is Taro's fourth approval by the FDA in the month of April," stated Barrie Levitt, M.D., Chairman of the Company. "Clorazepate is the latest product to come out of Taro's vertical integration program, through which Taro both synthesizes the active pharmaceutical ingredient, and manufactures the finished dosage form." Vertical integration ensures a high-quality and secure source of supply for active pharmaceutical ingredients. This program allows Taro to provide the highest possible quality product in the most cost-efficient manner. Etodolac Tablets, 500 mg Taro's Etodolac Tablets are indicated for use in the management of pain and the signs and symptoms of osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. . Etodolac Tablets are bioequivalent to Wyeth-Ayerst Laboratories' Lodine(R) Tablets. The US market for the Etodolac immediate release line is estimated by industry sources to be approximately $63 million, of which the 500 mg Tablet accounts for an estimated $18 million. Taro's Etodolac Tablets, 500 mg is an addition to Taro's previously approved Etodolac products, which include Etodolac Tablets, 400mg and Etodolac Capsules, 200mg and 300mg. With the approval of the 500 mg Tablets, Taro will launch its full line of Etodolac products. Etopan(R), Taro's brand of Etodolac in Israel, has become the Company's best-selling product in the Israeli market since its launch in 1998. Four Approvals in Second Quarter In April, Taro received FDA approval for its NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any for Clotrimazole clotrimazole /clo·trim·a·zole/ (klo-trim´ah-zol) an imidazole derivative used as a broad-spectrum antifungal agent. clo·trim·a·zole n. 3-Day Vaginal Cream, its ANDAs for Diflorasone Diacetate Cream and Clorazepate Dipotassium Tablets, and a supplemental ANDA approval for an additional strength of Etodolac Tablets. "Our latest approvals are the result of Taro's commitment to its R&D programs and its success in the development, manufacturing and marketing of quality pharmaceutical products," stated Dr. Levitt. Taro currently has multiple international regulatory filings, and nine 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, visit the Company's Web site 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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