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Teva Pharmaceutical Industries Ltd announces FDA acceptance of NDA filing for investigational short-acting beta-agonist (SABA) Inhaler (Albuterol MDPI)

Monday, 14 Jul 2014 08:00am EDT 

Teva Pharmaceutical Industries Ltd:Says U.S. Food and Drug Administration (FDA) has accepted for review company's new drug application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI), investigational breath-actuated dry-powder inhaler.Says for treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older.NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents (12 years of age and older) with asthma and exercise-induced bronchospasm (EIB).