Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) says that the US Food and Drug Administration (FDA) has accepted for review its new drug application (NDA) for an asthma treatment inhaler.
Teva's albuterol multi-dose dry-powder inhaler (MDPI) 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. The inhaler also prevents exercise-induced bronchospasm (EIB) in patients 12 years of age and older.
Teva VP Global Respiratory R&D Tushar Shah said, “If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients. As the current market-leader in asthma rescue inhalers, it is our hope that the new dry-powder innovation utilized with albuterol MDPI will help fill an unmet need in the existing asthma market.”
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 exercise-induced bronchospasm (EIB). The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
Published by Globes [online], Israel business news - www.globes-online.com - on July 14, 2014
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