Teva Says FDA Accepts For Review NDAs For Two Products

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food and Drug Administration has accepted for review the company's new drug applications or NDAs for two products for adolescent and adult patients with asthma.

The first, fluticasone propionate/salmeterol, is a fixed-dose combination inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) delivered via Teva's RespiClick breath-actuated, multi-dose dry powder inhaler (MDPI).

The second, fluticasone propionate, is an ICS monotherapy also delivered via the RespiClick device.

The NDAs for fluticasone propionate/salmeterol RespiClick and fluticasone propionate RespiClick have been accepted by the FDA for standard review with FDA Regulatory Action expected during the first quarter of 2017.