Taro Receives Tentative Approval for Augmented Betamethasone Dipropionate Lotion ANDA.HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) reported today that Taro Pharmaceuticals U.S.A., Inc., its U.S. affiliate, has received tentative approval 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. ") for 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 for Betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or Dipropionate Lotion (Augmented) USP USP - unique sales point , 0.05% ("augmented betamethasone dipropionate lotion"). The FDA has determined that Taro's augmented betamethasone dipropionate lotion is safe and effective for use when compared with the reference listed drug product, Schering Corporation's Diprolene(R) Lotion, 0.05% (Augmented). Augmented betamethasone dipropionate lotion is a prescription product used in managing inflammatory skin conditions. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. industry sources, Diprolene(R) lotion has annual U.S. sales of approximately $12 million. Taro U.S.A. also markets betamethasone dipropionate augmented cream, augmented ointment ointment /oint·ment/ (oint´ment) a semisolid preparation for external application to the skin or mucous membranes, usually containing a medicinal substance. oint·ment n. , and augmented gel, as well as betamethasone dipropionate cream, ointment, and lotion. The tentative approval for augmented betamethasone dipropionate lotion is an FDA determination that Taro's ANDA ANDA abbr. abbreviated new drug application submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities, restrictions and any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission. 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 www.taro.com. Certain statements in this release are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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, including statements regarding Taro's new augmented betamethasone dipropionate lotion product. 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; physician, pharmacist or patient acceptance of Taro's augmented betamethasone dipropionate lotion; 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. |
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