teva logo 88.
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Teva Pharmaceutical Industries Ltd. said Monday it received tentative approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for Adenosine Injection, 3 mg/ml in 20 ml and 30 ml single dose vials.
On final approval, the injection will be the AP-rated generic equivalent of Astellas Adenoscan Injection, a product used as an supplement to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
The brand product has annual sales of approximately $163 million.
Teva is currently in patent litigation over the product after a suit was brought against the company in May 2005. A trial is scheduled to begin in 2007.
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