Cipla Limited has announced that its wholly owned subsidiary, Cipla USA Inc., has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. This marks the first AB-rated generic therapeutic equivalent of Ventolin® HFA, originally marketed by GlaxoSmithKline.
Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and paediatric patients aged four years and older with reversible obstructive airway disease. It is also approved for the prevention of exercise-induced bronchospasm in the same age group.
The approval is a significant boost to Cipla’s respiratory portfolio in the United States, reinforcing its leadership in the albuterol inhalation category, which already includes approved generics for Ventolin® HFA and Proventil® HFA. According to IQVIA, the total U.S. albuterol market is valued at approximately $1.5 billion.
Achin Gupta, Managing Director & Global CEO of Cipla Limited, commented on the milestone, highlighting the company’s strong scientific and regulatory capabilities in complex inhalation products. He emphasised Cipla’s commitment to lung health and its objective to build a sustainable and differentiated portfolio for patients globally.
The product will be manufactured at Cipla’s newly constructed, dedicated inhalation facility in Fall River, Massachusetts, enhancing supply resilience and the company’s domestic manufacturing footprint in the U.S. Marc Falkin, CEO of Cipla North America, noted that the planned volume ramp-up is expected to make a meaningful difference in the lives of patients.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).