Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has accepted to review Teva Pharmaceuticals' new drug application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI), an investigational breath-actuated dry-powder inhaler to treat or prevent bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.
Subscribe to our email newsletter
Albuterol MDPI is also indicated for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older.
Teva senior vice president of Global Respiratory Research and Development Tushar Shah said the company is happy that 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," Shah said.
"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 filing of the application for albuterol MDPI includes data from eight clinical trials that assessed 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 has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.