Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, previously known as AMP-008. This product is for the treatment or prevention of bronchospasm in patients four years of age and older with irreversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients 4 years of age and older. The FDA determined that Amphastar's albuterol is bioequivalent and therapeutically equivalent to Teva Respiratory LLC's ProAir®?

HFA(albuterol sulfate) Inhalation Aerosol. Amphastar plans to launch its Albuterol Sulfate Inhalation Aerosol in the third quarter of 2024.