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Pharmaceuticals / Submissions and Approvals

FDA Approves Mylan’s Generic for Advair Diskus

Feb. 6, 2019

The FDA approved the first generic for GlaxoSmithKline’s asthma/chronic obstructive pulmonary disease drug Advair Diskus.

The agency approved Mylan’s 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. It is indicated for patients four years and older.

CDER Director Janet Woodcock said the approval will “bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

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