Teva gets final approval for generic DuoNeb
JERUSALEM The Food and Drug Administration has granted final approval to Teva Pharmaceuticals for its application for a generic version of Dey’s drug DuoNeb.
DuoNeb is a bronchodilator that increases airflow by dilating the bronchi and bronchioles. The generic, albuterol sulfate and ipratropium bromide inhalation solution will be available in 3 mg (0.083 percent) and 0.5 mg (0.017 percent).
The brand product had annual sales of approximately $265 million in the United States for the twelve months ended Sept. 30, 2007, based on IMS sales data. The company will begin shipping the product immediately.