Lupin’s ProAir HFA generic gets FDA green light

Lupin’s latest generic offering has passed muster with the Food and Drug Administration. The agency approved Lupin’s albuterol sulfate inhalation aerosol, 90 mcg/actuation, a generic of ProAir HFA. 

The drug is indicated to treat acute episodes of bronchospasm or prevention of asthmatic symptoms. 

“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,” said Vinita Gupta, Lupin CEO. “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 product had U.S. annual sales of $2.9 billion for the year ended June 2020, according to IQVIA, with the ProAir HFA market comprising $1.3 billion.