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,
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling
Sandoz's Tyruko (natalizumab-sztn) gains FDA approval as first biosimilar for relapsing MS
Nephron Pharmaceutical names new chief procurement officer
Lupin Pharmaceuticals launches Tiotropium Bromide Inhalation Powder, 18mcg/capsule in US