Chief executive Emma Walmsley, who took the top job last year, said forward guidance was dependent on the impact of a possible generic competition to Glaxo's Advair
asthma treatment in the US.
CEO Emma Walmsley said: ""Looking ahead, in 2018 we could see a potential generic version of Advair
in the US and our 2018 guidance reflects this.
The products that will no longer carry this boxed warning in their labels include AstraZeneca's budesonide/formoterol fumarate dihydrate (Symbicort) and GlaxoSmithKline's fluticasone furoate/vilanterol (Breo Ellipta) and fluticasone propionate/salmeterol (Advair
Diskus and Advair
Even more sales would come from generic availability of GlaxoSmithKline PLC's Advair
Diskus (fluticasone propionate and salmeterol inhalation powder), and Teva Pharmaceutical's Industries Ltd.
Sandoz today announced that the US Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application for fluticasone propionate / salmeterol combination product, a substitutable generic version of Advair
The US Food and Drug Administration (FDA) has rejected United Kingdom-based Vectura and its partner Hikma Pharmaceuticals' VR315, a generic version of GlaxoSmithKline's asthma/COPD inhaler, Advair
Diskus, it was reported on Friday.
(fluticasone propionate/salmeterol; GSK): Advair
and Symbicort have similar NPS scores.
Some big-selling products, like the respiratory medicine Advair
and the diabetes drug Victoza, have suffered precipitous declines in market share because Express Scripts, the biggest pharmacy benefits manager, recently stopped paying for them for many patients.
9 billion, with Advair
sales of [pounds sterling]1.
, GSK's blockbuster respiratory product, concerns over a generic version have dwindled given the FDA's increased scrutiny on finding the minimum effective dose of new products.
The inhaled corticosteroids evaluated were fluticasone, sold in combination with salmeterol as Advair
, and budesonide, sold in combination with formoterol as Symbicort.
One trial will evaluate Symbicort (budesonide and formoterol), a second trial will address Advair
Diskus (fluticasone and salmeterol), and a third will evaluate Dulera (mometasone and formoterol).