FDA Oks Mylan’s Generic of GSK’s Blockbuster Respiratory Drug Advair

By Patricia Van Arnum - DCAT Editorial Director

February 1, 2019

The US Food and Drug Administration (FDA) has approved the first generic of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder), a respiratory drug and one of the company’s top-selling drugs (Advair/Seretide) with 2017 global sales of £3.13 billion ($4.09 billion).

The FDA approved Mylan’s generic version for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Mylan obtained approval to market its generic inhaler in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg, and fluticasone propionate 500 mcg/ salmeterol 50 mcg.

Mylan said its generic product, Wixela Inhub, will launch in the second half of February of this year (2019).

Source: US Food and Drug Administration and Mylan