Drug major Cipla on Monday said it has submitted an application with the US health regulator for a generic version of GSK”s Advair Diskus, which is used in the treatment of asthma and other respiratory disorders.
The company has 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 US Food and Drug Administration (USFDA), Cipla said in a regulatory filing.
The drug firm had recently announced the successful completion of its phase-3 clinical end-point study for the product in the first attempt, it added.
The product 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.
According to IQVIA (IMS Health), Advair Diskus and its generic equivalents had US sales of around USD 2.9 billion for the 12-month period ending March 2020.
Cipla MD and Global CEO Umang Vohra 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.”
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