Cipla files ANDA for generic version of GSK’s Advair Diskus

18 May 2020 Evaluate

Cipla 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 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 $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.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.

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