Cipla Limited and its wholly owned subsidiary Cipla USA Inc. announced that the FDA has granted final approval for the company’s Abbreviated New Drug Application for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. 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 pediatric patients aged four years and older with reversible obstructive airway disease. It is also indicated for the prevention of exercise‑induced bronchospasm in patients aged four years and older.
Cipla noted that, according to IQVIA, the total U.S. albuterol market is valued at approximately 1.5 billion dollars. The company stated that this approval expands its U.S. respiratory portfolio and strengthens its position in the albuterol inhalation category, where it now has approved generics for both Ventolin HFA and Proventil HFA.
The newly approved product is supported by Cipla’s vertically integrated inhalation platform and will be manufactured at the company’s dedicated inhalation facility in Fall River, Massachusetts. Cipla indicated that this facility is part of its ongoing investment in U.S.-based manufacturing for complex respiratory therapies and is intended to support supply resilience and planned volume ramp-up.
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