Watson Receives FDA Approval For Generic DuoNeb
Watson Pharmaceuticals has received final approval from 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, 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 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.