Lupin gets USFDA’s nod for Generic Albuterol Sulphate MDI
25th Aug 2020

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation, a generic version of ProAir HFA. The company’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 $2.9 billion, of which the ProAir HFA market accounted for $1.3 billion (IQVIA MAT June 2020).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.