Cipla files ANDA for generic version of Advair Diskus
It is indicated as a twice-daily prescription medicine to treat asthma in patients aged four years and older
Mumbai: Cipla Limited announced its submission of 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 (USFDA).
The Company had recently announced the successful completion of its Phase-3 clinical end-point study for the product in the first attempt.
The product is the generic version of GSK's Advair Diskus®. According to IQVIA (IMS Health), Advair Diskus® and its generic equivalents had US sales of approximately US$2.9bn for the 12-month period ending March 2020.
It is indicated as a twice-daily prescription medicine to treat asthma in patients aged four years and older. It is also used in the long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.
Commenting on the filing, Mr Umang Vohra (MD and Global CEO, Cipla Limited) said, "We are pleased to announce the ANDA submission for generic Advair Diskus® to the USFDA. This marks a significant milestone and represents our commitment to increasing 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.
The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.
Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.
Cipla has 34 manufacturing units in 8 locations across India and a presence in over 80 countries.