Teva Pharmaceuticals Industries Ltd., (TEVA) Monday said the U.S. Food and Drug Administration has accepted for review the company's new drug application, or NDA, for the company's investigational bronchospasm inhaler.
The albuterol multi-dose dry-powder inhaler (MDPI) is indicated for treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease. The inhaler is also indicated for treating patients (12 years or older) who have exercise-induced bronchospasm.
"We are extremely pleased the FDA has accepted for review the NDA for albuterol MDPI. If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients," said Tushar Shah, Senior VP, Teva Global Respiratory Research and Development.
The company said the filing comprises of data poured in from eight clinical studies on adults and adolescents with asthma and exercise-induced bronchospasm.
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