The US Food and Drug Administration has granted a tentative approval for Teva's ANDA for adenosine injection, 3 mg/ml in 20 ml and 30 ml single dose vials.
Upon final approval, Teva's adenosine injection will be the AP-rated generic equivalent of Astellas Adenoscan injection, a product indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately, states the company release.
The brand product has annual sales of approximately $163 million.
Teva is currently in patent litigation concerning this product in the US District Court for the District of Delaware. A trial is scheduled to commence in 2007.
Teva Pharmaceutical Industries Ltd. is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.