FDA accepts Teva’s NDA for albuterol MDPI

15 July 2014

Israel-based generic giant Teva Pharmaceuticals Industries (NYSE: TEVA) says that the US Food and Drug Administration has accepted for review the company’s New Drug Application for albuterol multi-dose dry-powder inhaler (MDPI).

This is 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.

Teva's albuterol would fill unmet need in USA

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