Indian pharmaceutical company Cipla Limited (BSE:500087) (NSE:CIPLA-EQ) and its US subsidiary Cipla USA Inc announced on Thursday that the US Food and Drug Administration (FDA) has given final approval for the Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation.

Cipla said that the product is the first AB–rated generic therapeutic equivalent of Ventolin HFA, 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, as well as for the prevention of exercise-induced bronchospasm in patients aged four years and older.

According to IQVIA, the total US albuterol market is valued at approximately USD1.5bn.

This approval enhances Cipla's US respiratory portfolio, with approved generics for both Ventolin HFA and Proventil HFA.