Mylan Draws Hope From FDA’s Fluticasone Labelling Update

11 Jan 2019

• By Aidan Fry

Mylan sees supplemental labelling updates made by the FDA for all fluticasone-based medicines as a sign that approval for its Advair generic may be imminent.

RedFlag — Mylan sees no 'red flags' barring FDA approval of its generic rival to GSK's Advair Diskus inhaler • Source: Shutterstock

Labelling updates implemented by the US Food and Drug Administration (FDA) on 7 January for all medicines containing fluticasone have given Mylan fresh hope that US approval for its generic rival to GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) blockbuster may be imminent.

Chief executive officer Heather Bresch described the FDA’s move as “at least an indication of some of the administrative work”...