FDA accepts NDA for breath-actuated dry-powder inhaler
The FDA has accepted Teva Pharmaceutical Industries’ new drug application for its albuterol multi-dose dry-powder inhaler, according to a recent press release.
The breath-actuated dry-powder inhaler is being investigated for the treatment or prevention of bronchospasm in patients aged 12 years or older who have reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm (EIB) in patients aged 12 years or older, according to the release from Teva.
Data from eight clinical safety and efficacy studies of the albuterol multi-dose dry-powder inhaler (MDPI) in adults and adolescents with asthma and exercise-induced bronchospasm were included in the application filing, Teva reported.
“We are extremely pleased the FDA has accepted for review the [new drug application] for albuterol MDPI,” Tushar Shah, MD, senior vice president, Teva Global Respiratory Research and Development, said in the release. “If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients. 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.”
Regulatory action by the FDA is expected in March 2015, according to Teva.