Amphastar Bags FDA Approval for Albuterol Sulfate Inhalation Aerosol

Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) today 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 reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four 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.