Cipla Gets USFDA Nod for Generic Inhaler

New Delhi, Apr 23 (PTI) Pharma major Cipla Ltd on Thursday said it has received final approval from the US health regulator for its generic version of albuterol sulfate inhalation aerosol indicated for the treatment or prevention of bronchospasm.

The final approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Albuterol sulfate inhalation aerosol of strength 90 mcg per actuation, Cipla said in a regulatory filing.

It is the first AB-rated generic therapeutic equivalent of Ventolin HFA, marketed by GlaxoSmithKline, it added.

Commenting on the approval, Cipla Managing Director and Global CEO Achin Gupta said, "This marks an important milestone for Cipla and reflects our strong scientific and regulatory capabilities in complex inhalation products."


He further said, "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."

Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric 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, the company said.

Citing IQVIA data, Cipla said the total US albuterol market is valued at approximately USD 1.5 billion.

Cipla said the approval enhances its US respiratory portfolio and reinforces its leadership in the albuterol inhalation category, with approved generics for both Ventolin HFA and Proventil HFA.