Global pharmaceutical company, Cipla Limited, has submitted an Abbreviated New Drug Application (ANDA) which is a generic version of GSK’s Advair Diskus to the United States Food and Drug Administration (USFDA). This is in line with Cipla’s plan towards building a respiratory franchise in the US.
The company has submitted ANDA for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg). This generic version of Advair Diskus will help treat asthma 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.
The company announced the successful completion of its Phase three clinical end-point study for the product in the first attempt.
Commenting on the filing, Umang Vohra, MD and Global CEO, Cipla Limited, said, “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.”
According to IQVIA (IMS Health), Advair Diskus and its generic equivalents had US sales of approximately USD 2.9 billion for the 12-month period ending March 2020.