Events Details
Cipla Secures US FDA Approval for First AB-Rated Generic of Ventolin HFA
Friday, April 24, 2026
Cipla and its subsidiary Cipla USA have received final approval from the US Food and Drug Administration (FDA) for their Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. The product is the first AB-rated generic equivalent of Ventolin HFA, originally marketed by GlaxoSmithKline.
The inhalation aerosol is indicated for the treatment and prevention of bronchospasm in adults and children aged four years and above with reversible obstructive airway disease. It is also approved for the prevention of exercise-induced bronchospasm in the same age group.
The approval strengthens Cipla’s respiratory portfolio in the United States, where the albuterol market is valued at around $1.5 billion. The company now offers approved generic alternatives to both Ventolin HFA and Proventil HFA.
The product will be manufactured at Cipla’s dedicated inhalation facility in Fall River, Massachusetts. This reflects the company’s continued investment in US-based manufacturing and supports supply reliability for complex respiratory therapies.
The development highlights Cipla’s focus on expanding its presence in the inhalation segment and improving access to affordable treatment options for patients with respiratory conditions.
Source: prnewswire.com
