FDAnews Drug Daily Bulletin

The FDA has granted final approval to Watson Pharmaceuticals’ abbreviated new drug application for generic DuoNeb.

Dey’s DuoNeb (ipratropium bromide/albuterol sulfate) inhaled solution is indicated for treating bronchospasm associated with chronic obstructive pulmonary disease in patients requiring more than one bronchodilator.

Brand and generic versions of the drug had U.S. sales of approximately $265 million during the 12-month period that ended in September 2007, Watson said, adding that it intends to launch its product immediately.