14 OCTOBER - Abbott Laboratories (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to reintroduce Abbokinase(r) (urokinase) for the treatment of pulmonary embolism. Abbokinase is a thrombolytic therapy used to dissolve blood clots.
October 11, 2002 Abbott Laboratories Receives FDA Approval To Reintroduce Abbokinase(r) (Urokinase)[Internet Wire]ABBOTT PARK, ILOct 10, 2002, Internet Wire via NewsEdge Corporation : ABBOTT PARK, IL, Oct 10, 2002 /INTERNET WIRE/ -- Abbott Laboratories (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to reintroduce Abbokinase(r) (urokinase) for the treatment of pulmonary embolism. Abbokinase is a thrombolytic therapy used to dissolve blood clots. "Each year, more than half a million people develop pulmonary emboli. Effective treatment of this type of blood clot is critical to patients' well-being and - potentially - survival," said Kenneth Ouriel, M.D., chairman, department of vascular surgery, The Cleveland Clinic Foundation. "The return of Abbokinase is significant in that patients treated with Abbokinase in the past have experienced successful dissolution of their clots."Initially approved by the FDA in 1978, Abbokinase has been used to treat an estimated four million patients. The reintroduction of Abbokinase will return a proven product to the medical community and will provide patients with a safe and effective therapy. Regulatory History In early 1999, following an inspection of the manufacturing operations for Abbokinase and subsequent discussions with the FDA, Abbott suspended production of Abbokinase to address the FDA's issues regarding the manufacture of the product and to ensure compliance with the FDA's current good manufacturing practice (cGMP) requirements. Since that time, Abbott has upgraded its manufacturing facility and validated additional controls throughout the Abbokinase production process. The company has also implemented multiple layers of additional testing as further safeguards for detecting potential issues in the manufacture of a biologic product like Abbokinase. As a result, Abbott has completed the necessary steps to reintroduce the product and has demonstrated that the Abbokinase manufacturing operations are in accordance with cGMP requirements. "In keeping with Abbott's commitment to provide needed health care products, we have worked diligently to return Abbokinase to the medical community," said Christopher B. Begley, senior vice president, Hospital Products, Abbott Laboratories. "The reintroduction of Abbokinase is a notable milestone that allows patients to benefit once again from this potentially life-saving therapy."Safety Information The most serious drug-related adverse reaction to Abbokinase is bleeding. Mild to moderate allergic-type reactions and rare cases of anaphylaxis have been reported. Infusion reactions generally characterized by fever, chills and rigors have also been reported. Abbokinase should not be used in people who are at risk for bleeding complications, have uncontrolled hypertension or who have had an allergic Type-III reaction to urokinase. Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. In 2001, the company's sales and net earnings were $16.3 billion and $2.9 billion, respectively, with diluted earnings per share of $1.88, excluding one-time charges. Abbott's news releases and other information are available on the company's Web site at www.abbott.com. Contact: Stacey Eisen Phone: 847-935-2828Contact: Tareta Lewis Phone: 847-938-4310Contact: John Thomas Phone: 847-938-2655