Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has granted approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of AstraZeneca’s Pulmicort (Budesonide) Respules®, 0.25 mg/2 mL and 0.5 mg/2 mL indicated for twice daily treatment of Asthma.
Total annual sales of these strengths of the brand product were approximately $996 million in the United States for the twelve months that ended September 30, 2008 based on IMS sales data.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial has been scheduled for January 12, 2009. Shipment of these products has commenced.