Lupin gets US FDA approval for generic Albuterol Sulphate MDI

Lupin announced that it has received approval from the United States Food and Drug Administration (US 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, and is indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

Commenting on the development, Vinita Gupta, CEO, Lupin said, “Approval of our generic Albuterol MDI is a significant milestone in our complex generics evolution and a validation of our Inhalation team’s development capabilities, backed by our global manufacturing strength in handling multiple dosage forms. The approval is timely as Albuterol MDI is a key rescue inhalation product for asthma patients who are at an increased risk of COVID-related complications. We look forward to launching the product this quarter and expect a steady ramp- up through the fiscal year.”

The total Albuterol Sulfate Inhalation Aerosol market had US sales of approximately $2.9 billion, of which the ProAir HFA market accounted for $1.3 billion (IQVIA MAT June 2020).