Abbokinase Returns to Market
According to the product's new labeling, Abbokinase is indicated for the lysis of acute massive pulmonary emboli and pulmonary emboli accompanied by unstable hemodynamics. The labeling specifies use in adults, not children.
The product was initially granted marketing approval in 1978. Previously approved labeling had included indications for the lysis of pulmonary and coronary artery emboli and for the clearance of occluded intravenous catheters.
Abbott's decision to withdraw Abbokinase from the market in 1999 was prompted by FDA's discovery of major deviations from good manufacturing practices at an Abbott manufacturing facility and at BioWhittaker Inc., which supplied the human kidney cells from which Abbokinase is derived.
A July 16, 1999, FDA talk paper stated that six inprocess lots of Abbokinase were found to be contaminated with reovirus, and an additional lot harbored Mycoplasma organisms. FDA stated that it was assured by Abbott that none of these lots was used to make the finished product.
In addition to the contamination problems, FDA said that the agency was dissatisfied with the procedures used by Abbott to screen and test the kidney-cell donors.
Abbott spokeswoman Tareta Lewis said the company has focused since 1999 on "getting up to speed" on current good manufacturing practices related to Abbokinase production.
"We spent a lot of time and worked very hard as a company to complete the necessary steps," she said. "We feel very good about the fact that the FDA is comfortable with the [supplemental new drug] submission we put forth, and that we'll be able to get the product back to physicians and pharmacists."
Lewis said this morning that FDA approved the supplemental new drug application less than 24 hours ago, and the company is working to make Abbokinase immediately available for distribution.
She noted that when Abbott filed the application last December, the company narrowed the product's indication to pulmonary embolism to speed the approval process.
"Our goal was to get this product back to patients and physicians as quickly as we possibly can," she said. "Focusing on that particular indication was the best way to do so."