Cipla submitted an Abbreviated New Drug Application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg, and 500/50 mcg) to the United States Food and Drug Administration (US FDA).

It had recently announced the completion of Phase 3 clinical trial of the drug, which is a generic version of GSK’s Advair Diskus.

The medicine is a twice-daily prescription to treat asthma in patients aged four years and older. In the long term, it could also be used to treat chronic constructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.

Commenting on the filing, Umang Vohra (MD and Global CEO, Cipla) said, “We are pleased to announce the ANDA submission for generic Advair Diskus® to the US FDA. This marks a significant milestone and represents our commitment to increase patient access to complex treatment options in the respiratory space and will also play a major role in our strategy towards building a respiratory franchise in the US. Our unparalleled range of offerings in this space has established our position as lung leaders in India and emerging markets and we intend to extend this offering to our developed markets.”

Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, and depression; other medical conditions. As of 17 September 2014, its market capitalization was ₹49,611.58 crore (equivalent to ₹530 billion or US$7.5 billion in 2019), making it India's 42nd largest publicly traded company by market value.