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).

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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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