Hikma launches FDA approved generic Advair Diskus
18 December 2020 -

Pharmaceutical company Hikma Pharmaceuticals plc (LON:HIK) revealed on Thursday that it has received US Food and Drug Administration (FDA) approval for and launched its generic version of GlaxoSmithKline's Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg, in the United States.

The fixed dose combination product contains an inhaled corticosteroid (ICS) and a long-acting beta-adrenergic agonist (LABA) and is indicated for the twice-daily treatment of asthma in patients aged 4 years and older.

Hikma worked with Vectura Group (LON:VEC), a UK-based provider of inhaler drug delivery solutions, to develop the proprietary dry powder inhaler and formulation technology.

For the 12 months ending September 2020, US sales of Fluticasone Propionate and Salmeterol Inhalation Powder USP, 100mcg/50mcg and 250mcg/50mcg, were approximately USD2bn, according to IQVIA,