Advair Competition: Teva’s AirDuo Approved But Not Therapeutically Equivalent

31 Jan 2017

US FDA approves Teva’s fluticasone/salmeterol fixed-dose combination product under the 505(b)(2) NDA route with an asthma indication but no labeling claim for chronic obstructive pulmonary disease.

Teva Pharmaceutical Industries Ltd. used the 505(b)(2) regulatory pathway to bypass the need for demonstrating bioequivalence to GlaxoSmithKline PLC’s blockbuster Advair Diskus (fluticasone/salmeterol).

On Jan. 27, the US FDA approved Teva’s AirDuo RespiClick, a fixed-dose combination of the same ingredients in Advair: the...