The FDA approved an Abbreviated New Drug Application for Lupin Ltd’s albuterol sulfate inhalation aerosol 90 mcg (base)/actuation, a generic for Teva’s ProAir HFA.

Albuterol sulfate inhalation aerosol 90 will be used for the treatment or prevention of bronchospasm (narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients four years of age and older.

The most common side effects associated with albuterol sulfate inhalation aerosol are headache, rapid heart rate (tachycardia), pain, dizziness, sore throat (pharyngitis), and rhinitis.

“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, CEO, Lupin. “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.”

Lupin’s generic Albuterol Sulphate MDI will be manufactured at its Indore (Unit III) facility in India.

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), according to Lupin.