The FDA has approved Teva’s supplemental NDA for ProAir RespiClick albuterol breath-activated DPI for the treatment or asthma in children aged 4 to 11, the company has announced. The sNDA filing was accepted by the FDA in September 2015. ProAir RespiClick has been approved by the FDA for patients 12 years old and older since March 2015.
Erwin Gelfand, Chairman, Department of Pediatrics at National Jewish Health, commented, “For this young population of asthma patients, learning to use inhalers properly can be quite challenging. Thus, the pediatric indication for ProAir RespiClick is important as it represents a new rescue inhaler option for younger patients that eliminates the need for hand-breath coordination during inhalation and was designed to be used without a spacer.”
Teva Senior VP, Global Respiratory Research and Development, Tushar Shah 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. 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.”
Read the Teva press release.
