Taro Pharmaceutical Industries announces FDA approval.HAWTHORNE, N.Y.--(BUSINESS WIRE)--June 2, 1997-- Acetazolamide tablets represent third U.S. approval for solid dosage form products Taro Pharmaceutical Industries Ltd. (Nasdaq/NMS: TAROF) Monday reported that it 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 Acetazolamide Tablets USP USP - unique sales point , in strengths of 125 mg and 250 mg. "Acetazolamide is Taro's third solid dosage form preparation to receive approval from the FDA," stated Rebecca Pike, group vice president North America of Taro Pharmaceuticals U.S.A. Inc. "We already market carbamazepine carbamazepine /car·ba·maz·e·pine/ (kahr?bah-maz´e-pen) an anticonvulsant and analgesic used in the treatment of pain associated with trigeminal neuralgia and in epilepsy manifested by certain types of seizures. tablets and clomipramine clomipramine /clo·mip·ra·mine/ (klo-mip´rah-men) a tricyclic antidepressant with anxiolytic activity, also used in obsessive-compulsive disorder, panic disorder, bulimia nervosa, cataplexy associated with narcolepsy, and chronic, severe capsules, which were approved for the U.S. market in late 1996. This approval is part of Taro's strategy for developing a presence in the U.S. market for central nervous system products." Acetazolamide belongs to a group of drugs called carbonic anhydrase inhibitors Carbonic anhydrase inhibitors are a class of pharmaceuticals that suppress the activity of carbonic anhydrase. Types Acetazolamide is an inhibitor of carbonic anhydrase. It is used for glaucoma, epilepsy (rarely), benign intracranial hypertension, and altitude sickness. . The drug has several therapeutic applications, including the treatment of glaucoma and certain types of epilepsy. The Company will manufacture acetazolamide tablets at its facilities in Haifa, Israel. Taro's acetazolamide tablets are bioequivalent to Diamoxr Tablets. The U.S. market for Acetazolamide Tablets USP, 125 mg and 250 mg is estimated by industry sources to be approximately $5 million. Taro Pharmaceutical Industries Ltd. is a multinational pharmaceutical company whose research and development program has resulted in the Company being the first generic marketer of several branded drugs as well as the developer of several novel pharmaceutical compounds. For further information on Taro Pharmaceutical Industries, please visit the company's home page at http://www.taropharma.com . To receive additional information on Taro Pharmaceutical Industries, at no charge, dial 800/PRO-INFO and enter company code "TAROF." Diamox is a registered trademark of Lederle Laboratories CONTACT: Taro Pharmaceutical Industries Peter Giallorenzo, 914/345-9001 or The Financial Relations Board Inc. Daniel Saks/David Lawton Kathy Brunson Steven Seiler General Info. Analyst Info. Media Info. 310/442-0599 312/266-7800 310/442-0599 |
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