Teva has announced the FDA’s acceptance of the company’s NDAs for fluticasone propionate (FP)/salmeterol and FP monotherapy DPIs for the treatment of asthma. Both products are delivered using the breath-activated RespiClick inhaler. In late 2015, Teva announced positive data from Phase 3 studies of both products.
The FDA is expected to take action on both applications during the first quarter of 2017. Earlier this year, Mylan announced a GDUFA date in March 2017 for its ANDA for a fluticasone propionate/salmeterol DPI.
Teva Senior VP, Global Respiratory Research and Development, Tushar Shah said, “Acceptance of these two filings represents an exciting time for Teva’s specialty respiratory medicines business as we integrate both fixed dose combination and monotherapy into our core, breath-actuated RespiClick device. By utilizing our RespiClick inhaler platform, we will be able to deliver these established medications at a lower dosage while eliminating the need for hand-breath coordination during inhalation. We are pleased to proceed with the review of these applications, aiming to ultimately provide a complete breath-actuated asthma management system to help meet the needs of patients with asthma.”
Read the Teva press release.
