FDA expands indication for Teva’s ProAir RespiClick

 

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Teva’s ProAir RespiClick (albuterol sulfate) inhalation powder to treat or prevent bronchospasm in children aged 4 to 11 years. The drug had previously been approved for the same indication in patients older than 12. 

 

The drug is the only breath-activated multi-dose short-acting beta agonist, inhaler in the U.S., Teva said. 

 

“We are very pleased with the FDA’s decision to expand the indication of ProAir RespiClick for the treatment of patients as young as four years of age,” Teva SVP global respiratory research and development Dr. Tushar Shah said. “The availability of this treatment option for younger patients is a demonstration of Teva’s commitment to optimizing respiratory therapies through the development of new delivery systems that help address needs in the marketplace.”