Watson receives FDA approval for generic DuoNeb

Jan 3 2008

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.).

Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution in the 0.5 mg/3 mg strength.

Watson's Ipratropium Bromide and Albuterol Sulfate product is the generic equivalent to Dey, L.P.'s DuoNeb(R), which is indicated for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients requiring more than one bronchodilator. For the 12 months ending September 2007, DuoNeb(R) and its generic equivalents had total U.S. sales of approximately $265 million, according to IMS Health data. Watson intends to launch its Ipratropium Bromide and Albuterol Sulfate product immediately.