According to Teva Pharmaceutical Industries, the FDA has approved 3 strengths each for the AirDuo RespiClick fluticasone propionate/salmeterol DPI and the ArmonAir RespiClick fluticasone propionate DPI for the treatment of asthma in patients aged 12 and older. Both the AirDuo RespiClick and the ArmonAir RespiClick are approved for twice daily use and both are expected to launch in the US sometime in 2017.
Teva announced the FDA’s acceptance of NDAs for both inhalers in June 2016. Top-line data from the Phase 3 trials that were used to support the applications were announced in November 2015.
Teva President and CEO of Global Specialty Medicines Rob Koremans commented, “With these approvals, we now integrate both fixed dose combination and monotherapy into our core, breath-activated RespiClick device. By expanding our RespiClick portfolio of breath-activated inhalers, we will provide physicians and their patients with additional treatment options in an inhaler device that does not require hand-breath coordination during inhalation.”
Read the Teva press release.
