India, April 23 -- Cipla Limited, along with its subsidiary Cipla USA Inc., has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol (90 mcg).
The approval marks the launch of the first AB-rated generic equivalent of Ventolin HFA, originally marketed by GlaxoSmithKline. The inhaler is used to treat and prevent bronchospasm in patients aged four years and above, including those with reversible airway diseases and exercise-induced bronchospasm.
With the U.S. albuterol market estimated at around $1.5 billion, this approval strengthens Cipla's respiratory portfolio and solidifies its presence in the inhalation segment, where it now ...