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Teva Pharmaceutical Industries announced today 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
JERUSALEM, ISRAEL | November 19, 2008 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) announced today 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. Shipment of these products has commenced.
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.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's 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. Over 80 percent of Teva's sales are in North America and Europe.
SOURCE: Teva Pharmaceutical Industries Ltd. |
