Cipla submits application with USFDA

DRUG major Cipla 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 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 $2.9 billion for the 12-month period ending March 2020.