Cipla Limited (Cipla) has announced it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation from the United States Food and Drug Administration (USFDA).
It is the first AB-rated generic therapeutic equivalent of Ventolin HFA, which is produced by GlaxoSmithKline.
Albuterol Sulfate Inhalation Aerosol is used to treat or prevent bronchospasm in adults and children who are four years old and older with reversible obstructive airway disease.
It is also indicated for the prevention of exercise-induced bronchospasm in patients aged four and older.
According to IQVIA, the total US albuterol market is valued at approximately $1.5bn.
This approval enhances Cipla's US respiratory portfolio, with the firm now having approved generics for both Ventolin HFA and Proventil HFA.
Achin Gupta, Managing Director & Global CEO, Cipla Limited, said: "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.
The product is backed by Cipla's vertically integrated inhalation platform, reflecting the company's continued investment in US-based manufacturing for complex respiratory therapies.
Marc Falkin, CEO, Cipla North America, added: "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 a meaningful difference in the lives of patients.