Abbott receives FDA approval to reintroduce Abbokinase
ABBOTT PARK, ILL., Oct.10, 2002 -- Abbott Laboratories announced that the FDA has approved its supplemental new drug application (sNDA) to reintroduce Abbokinase (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.
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 then, 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.
Source: Abbott Laboratories www.abbott.com
Posted: October 2002