Cipla files ANDA for generic version of Advair Diskus
It is indicated as a twice-daily prescription medicine to treat asthma in patients aged four years and older;
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Mumbai: Cipla Limited announced its submission of 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 US$2.9bn for the 12-month period ending March 2020.
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