Cipla has received FDA approval of its ANDA for a generic version of Ventolin HFA albuterol MDI for the treatment of asthma, the company announced. GSK’s NDA Ventolin HFA was approved by the agency in 2001, and the Cipla albuterol MDI is the first approved generic equivalent. Cipla already markets a generic version of Proventil HFA albuterol MDI in the US; that product was approved by the FDA in 2020.
Cipla Managing Director & Global CEO Achin Gupta commented, “This marks an important milestone for Cipla and reflects our strong scientific and regulatory capabilities in complex inhalation products. Lung health remains at the heart of all our offerings and follows a singular, distilled objective, to build a sustainable and differentiated portfolio for patients globally.”
Cipla North America CEO Marc Falkin said, “Strengthening our US respiratory franchise, the product will be manufactured at our newly constructed, dedicated inhalation facility in Fall River, Massachusetts, reinforcing both supply resilience and our domestic manufacturing footprint. With planned volume ramp-up, we expect to drive meaningful difference in the lives of patients.
Read the Cipla press release
