FDA accepts Teva's NDAs for two asthma candidates

• The FDA accepts for review two New Drug Applications (NDAs) from Teva Pharmaceutical Industries (NYSE:TEVA) seeking approval of fluticasone propionate/salmeterol, a fixed-dose combination inhaled corticosteroid and long-acting beta agonist delivered via the RespiClick inhaler, and fluticasone propionate as monotherapy, also delivered via RespiClick, for the treatment of adolescents and adults with asthma.
• Both applications will be assessed via standard review with an expected action date in Q1 2017.
• RespiClick is a breath-actuated, dry powder inhaler that eliminates the need for hand-breath coordination during inhalation.