FDA Accepts Teva’s NDA for Albuterol MDPI

Teva Pharmaceuticals Industries Ltd. reports that the US Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI), an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older.

The 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 EIB. The NDA for albuterol MDPI has been accepted by the FDA for standard review with a FDA regulatory action expected in March 2015.

Source: Teva Pharmaceuticals Industries

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