Teva Pharmaceutical Industries Ltd announced that the US Food and Drug Administration has granted final approval for the Company's ANDA for Adenosine Injection USP, 3 mg/ml, which was submitted by the Company's subsidiary SICOR Inc.
Teva's Adenosine Injection USP is the generic equivalent of Fujisawa's Adenocard Injection. This product is indicated for conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome).
Teva Pharmaceutical Industries Ltd develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90 per cent of Teva's sales are in North America and Europe.
The brand product has annual sales of approximately $13 million.
Shipment of this product, which has been approved in 2 ml and 4 ml vials, is expected to begin immediately.