Taro Pharmaceutical Industries announces two FDA approvals.HAWTHORNE, N.Y.--(BUSINESS WIRE)--Jan. 2, 1997-- Agency approves Clomipramine Hydrochloride clomipramine hydrochloride a tricyclic antidepressant. clomipramine hydrochloride Anafranil, Apo-Clomipramine (CA), Gen-Clomipramine (CA), Novo-Clopamine (CA) Pharmacologic class: Tricyclic antidepressant (TCA) Capsules and Fluocinonide Solution; company received seven ANDA ANDA abbr. abbreviated new drug application approvals in 1996 Taro Pharmaceutical Industries Ltd. (NASDAQ/NMS:TAROF) Thursday reported receiving 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 Clomipramine Hydrochloride Capsules, 25 mg, 50 mg and 75 mg, as well as an ANDA for Fluocinonide Solution USP USP - unique sales point , 0.05 percent, by the company's wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , Taro Pharmaceuticals Inc., of Ontario. ``Taro's substantial R&D program produced impressive results in 1996, with seven ANDA approvals during the year,'' said Barrie Levitt, M.D., chairman of the company. ``These approvals are a tribute to the company's talented R&D team. We look forward in 1997 to further approvals in the United States, Canada, Israel and other countries for the company's finished dosage-form products as well as bulk active raw materials synthesized by the company.'' Clomipramine hydrochloride, a tricyclic antidepressant commonly used to treat obsessive-compulsive disorders, 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 Anafranil Capsules. The market for the three strengths of Clomipramine Hydrochloride Capsules in the United States is estimated by industry sources to be approximately $48 million. Clomipramine hydrochloride is the second product to be approved by the FDA for manufacture in the company's Israeli facilities. The first was 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 USP, 200 mg, which received approval in late 1996. Fluocinonide solution, a topical corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and commonly used in the treatment of dermatologic disorders, is bioequivalent to Lidex Topical Solution, 0.05 percent. The U.S. market for Fluocinonide Solution USP, 0.05 percent, is estimated by industry sources to be approximately $4.7 million. The fluocinonide-solution approval enhances Taro's already- extensive line of topical corticosteroids and complements its existing fluocinonide-cream and fluocinonide-emollient-cream products. The combined U.S. market for these three products is estimated by industry sources to be approximately $18.1 million. Taro currently has multiple regulatory filings in Canada and Israel and 10 ANDAs submitted to the FDA. Taro Pharmaceutical Industries is a multinational pharmaceutical company whose research and development program has made it 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, visit the company's home page at http://www.taropharma.com . To receive additional information on Taro via fax at no charge, dial 800/PRO-INFO and enter company code 104 or ticker symbol TAROF. -0- NOTE TO EDITORS: Anafranil is a registered trademark of Novartis Inc. Lidex is a registered trademark of Roche Laboratories. CONTACT: Taro Pharmaceutical Industries Ltd., Hawthorne Tal Levitt, 914/345-9001 or The Financial Relations Board Inc., Los Angeles Daniel Saks, 310/442-0599 |
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