Albuterol MDPI NDA Accepted for Review for Bronchospasms
Teva announced that the FDA has accepted for review its New Drug Application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI) for the treatment or prevention of bronchospasm in patients ≥12 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB) in patients ≥12 years of age. Albuterol MDPI, a breath-actuated dry-powder inhaler is an investigational short-acting beta-agonist (SABA).
The NDA submission includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in patients 12 years of age and older with asthma and exercise-induced bronschospasm.
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