Taro Receives Approval for Ciclopirox Topical Suspension USP, 0.77% ANDA; Generic Equivalent to Loprox(R) Topical Suspension, 0.77%.HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. ("Taro," Nasdaq: TARO) reported today that Taro Pharmaceuticals U.S.A., Inc. ("Taro USA") has received approval from the U.S. 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 Ciclopirox Topical Suspension USP USP - unique sales point , 0.77% ("ciclopirox topical suspension"). Taro's ciclopirox topical suspension is a prescription pharmaceutical product used for the treatment of fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. of the skin. The Taro product 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 Medicis Pharmaceutical Medicis Pharmaceutical is a pharmaceutical company headquartered in Scottsdale, Arizona. One of their divisions is Ucyclyd Pharma. External links
Taro USA also markets Ciclopirox Olamine ci·clo·pir·ox ol·a·mine n. A broad-spectrum antifungal agent used in the treatment of a variety of fungal and yeast infections of the skin. ciclopirox olamine (sik´lōpē´roks) (topical), Cream USP, 0.77%. Taro and its subsidiaries manufacture and market a broad line of prescription and over-the-counter antifungal products. 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, please visit www.taro.com. 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, including statements regarding the Company's ciclopirox products and other antifungal products. 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 ciclopirox products and other antifungal 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. |
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