US regulators have agreed to review Teva's application to market its bronchospasm therapy albuterol multi-dose dry-powder inhaler (MDPI).
The new drug application is seeking approval for the short-acting beta-agonist to treat or prevent 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 aged 12 and above.
The company said its filing contains data from eight clinical studies involving adults and adolescents with asthma and EIB.
If approved, albuterol MDPI will become the first breath-actuated dry-powder symptomatic and rescue inhaler available to patients with asthma, said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “It is our hope that the new dry-powder innovation utilised with albuterol MDPI will help fill an unmet need in the existing asthma market," he added.
A response by the US Food and Drug Administration is expected in March next year.