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...
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