Lupin announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation, a generic version of ProAir® HFA. Lupin's generic Albuterol Sulphate MDI will be manufactured at its Indore (Unit III) facility in India.
ProAir® HFA (Albuterol Sulfate Inhalation Aerosol) is the registered trademark of Teva Branded Pharmaceutical Products R&D, Inc. (Teva) and is indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.
The total Albuterol Sulfate Inhalation Aerosol market had U.S. sales of approximately US$2.9 billion, of which the ProAir® HFA market accounted for US$1.3 billion (IQVIA MAT June 2020).