Lupin gets USFDA nod to generic version of ProAir HFA

Mumbai: Pharma major Lupin Limited 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.

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 rampup through the fiscal year."

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).

Read also: Lupin, ForDoz Pharma Ink Deal For Development Of 2 Complex Injectable Products

Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.

Read also: Lupin Presents Phase 3 Data For Solosec In Female Trichomoniasis Patients