Cipla submitted an application for generic version of asthma drug to USFDA


2020-05-18 16:58:32



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.