FDA Approves Akorn ANDA For Diltiazem HCl Injection; Baxter Pharmaceutical Products, Inc. To Market Worldwide.LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--May 12, 1998-- Akorn and Baxter in Alliance to Develop, Produce and Market Injectables Worldwide Akorn, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AKRN) announced today that it has received 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. approval of its ANDA ANDA abbr. abbreviated new drug application application of Diltiazem HCl diltiazem HCl (diltī´  zem),n brand names: Cardizem, Cardizem SR, Cardizem CD; drug class: calcium channel blocker; action: injection. Akorn's Injectable Division, Taylor Pharmaceuticals, has entered into a strategic alliance with Baxter Pharmaceutical Products, Inc. to market Diltiazem throughout the world. This launch is the first part of an alliance in which Taylor and Baxter will jointly develop, manufacture and market four injectable products with current sales in excess of $200 million: Ketorolac Tromethamine ketorolac tromethamine Acular, Acular LS Pharmacologic class: Nonsteroidal anti-inflammatory drug (NSAID) Therapeutic class: Analgesic, antipyretic, anti-inflammatory Pregnancy risk category C Injection, Amrinone Lactate Injection, Diltiazem HCl Injection and Labetalol HCl Injection. Ketorolac Tromethamine Injection is indicated for the management of pain. Amrinone Lactate Injection is indicated for the management of congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. . Diltiazem HCl Injection is indicated for atrial flutter and for paroxysmal supraventricular tachycardia paroxysmal supraventricular tachycardia Supraventricular tachycardia Cardiology Tachycardia triggered sporadically in the myocardium above the ventricles; PSVT is most common in younger subjects with normal hearts Risk factors Smoking, caffeine, stress, alcohol . Labetalol HCl Injection is indicated for control of blood pressure in severe hypertension. Floyd Benjamin, President of Taylor Pharmaceuticals, stated, "Access to generic markets for Diltiazem is already available, and Baxter anticipates launching the product this month. The additional injectable products under the alliance with Baxter will be launched once ANDA approvals are obtained. Taylor Pharmaceuticals believes that the alliance with Baxter Pharmaceutical Products, Inc. is positioned to profitably penetrate these markets." Akorn Inc. manufactures and markets sterile ophthalmic and injectable pharmaceuticals, and markets and distributes an extensive line of ophthalmic products. The information contained in this news release, other than historical information, consists of forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those described in such statements. Such statements regarding the timing of acquiring and developing new products, of bringing them on line and of deriving revenues and profits from them, as well as the effects of those revenues and profits on the company's margins and financial position, is uncertain because many of the factors affecting the timing of those items are beyond the company's control. This press release is available on the KCSA KCSA Krannert Center Student Association KCSA Kentucky Crushed Stone Association (Frankfort, KY) KCSA Kyiv City State Administration KCSA Kalamazoo Christian School Association KCSA Kentucky-Canadian Studies Association Worldwide web site at www.kcsa.com. CONTACT: Akorn Inc., Lincolnshire Rita McConville, Chief Financial Officer 847/236-3851 or KCSA Worldwide, New York Paul Holm/Joseph A. Mansi 212/682-6300 ext. 201/205 |
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