FDA Accepts Two NDAs from Teva for Respiratory Drugs

The US Food and Drug Administration (FDA) has accepted for review Teva Pharmaceutical Industries’ new drug applications (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.

Source: Teva Pharmaceutical Industries

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