The study results demonstrate that Cipla's fluticasone propionate and salmeterol inhalation powder 100/50 mcg is therapeutically equivalent to Advair Diskus 100/50 mcg, Cipla said in a statement.
The Phase-3 study, which successfully completed in the first attempt, was conducted over a period of 15 months at over 100 sites in the US enrolling 1,400 asthma patients, it added.
"This is an important milestone and is a testament to Cipla's strong respiratory capabilities and will go a long way in strengthening our respiratory franchise in the US," Cipla MD and Global CEO Umang Vohra said.
Unmatched presence across the care continuum and the widest range of drug-device combinations has established Cipla's position as a lung leader in India and other key emerging markets, he added.
"Our endeavour is to extend this expertise across developed markets through niche product development," Vohra said.
According to IQVIA, Advair Diskus and its generic equivalents registered a total US sales of approximately USD 2.9 billion for the 12-month period ending February 2020, Cipla said.
The product is indicated to treat asthma in patients of 4 years and older as a twice-daily prescription medicine and in long-term to treat chronic obstructive pulmonary disease, including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups, it added. AKT BALBAL