Cipla Achieves Milestone with USFDA Nod for Albuterol Inhaler

Cipla Ltd has gained final USFDA approval for its generic albuterol sulfate inhalation aerosol, used to treat bronchospasm. This approval highlights Cipla’s expertise in inhalation products and marks its first AB-rated generic version of Ventolin HFA. The US albuterol market is valued at $1.5 billion.

Pharmaceutical giant Cipla Ltd announced on Thursday that it has secured final approval from the US Food and Drug Administration for its generic albuterol sulfate inhalation aerosol. This product is indicated for treating and preventing bronchospasm.

The approved dosage strength is 90 mcg per actuation, marking Cipla's first AB-rated generic equivalent of Ventolin HFA, which is marketed by GlaxoSmithKline.

Cipla Managing Director and Global CEO Achin Gupta celebrated the achievement, calling it a significant milestone that underscores Cipla's leadership in the respiratory sector. The US albuterol market is worth approximately USD 1.5 billion, according to IQVIA data.