Teva announces tentative FDA approval of Adenosine injection

By Lisa Kerner

Erie, Pa., Feb. 13 - Teva Pharmaceutical Industries Ltd. said that the U.S. Food and Drug Administration has granted tentative approval for its Abbreviated New Drug Application 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, indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately, according to a company news release.

The brand product has annual sales of approximately $163 million.

Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of Delaware. A suit was brought against Teva in May 2005 and a trial is scheduled to begin next year.

Teva, based in Jerusalem, develops, manufactures and markets generic and human pharmaceuticals and active pharmaceutical ingredients.

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