Taro Pharmaceuticals Announces FDA Approval; Agency Approves ANDA For Diflorasone Diacetate Cream USP, 0.05%.Business Editors/Pharmaceuticals Writers HAWTHORNE, New York--(BUSINESS WIRE)--April 25, 2000 Taro Pharmaceutical Industries Ltd. (NasdaqNM:TARO) today reported that Taro Pharmaceuticals Inc., the Company's wholly owned Canadian subsidiary, 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 ANDA abbr. abbreviated new drug application ) for Diflorasone Diacetate Cream USP USP - unique sales point , 0.05%. Taro's Diflorasone Diacetate Cream is a high-potency topical corticosteroid indicated for the treatment of moderate to severe dermatologic conditions. Diflorasone Diacetate Cream is 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 Dermik Laboratories' Psorcon(R) Cream. The U.S. market for Diflorasone Diacetate Cream is estimated by industry sources to be approximately $15 million. "Taro's May 1999 approval for Diflorasone Diacetate Ointment USP, 0.05%, combined with this most recent approval, further expands Taro's extensive line of topical corticosteroid products and reinforces Taro's position as a leading developer, manufacturer and marketer of quality generic creams and ointments," stated Barrie Levitt, M.D., Chairman of the Company. Second Approval in Second Quarter Diflorasone Diacetate Cream is the second approval this quarter for Taro. Earlier in April, Taro's 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 over-the-counter 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. Three-Day Vaginal Cream, 2%, was approved by the FDA. 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 health care products. For further information on Taro Pharmaceutical Industries, 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 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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