Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company’s abbreviated new drug application (ANDA) to market its generic version of Dey’s bronchodilator, DuoNeb Inhalation Solution in 3 mg (0.083%) and 0.5 mg (0.017%) strengths. The product contains two medicines - Albuterol Sulfate and Ipratropium Bromide. Shipment of the product will begin immediately.
Bronchodilators are medicines that open up the bronchial tubes. They are often delivered by inhalation. Dey's DuoNeb is delivered via nebulizers. DuoNeb is used as a treatment for COPD chronic obstructive pulmonary disease.
The brand product had annual sales of approximately $265 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
Petah Tikva-based Teva is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company.
Shares in Teva rose 1.1% in Nasdaq trading on Wednesday.
Published by Globes [online], Israel business news - www.globes-online.com - on January 3, 2008
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