Cipla has submitted an ANDA for a generic version of GSK’s Advair Diskus fluticasone propionate/salmeterol DPI in 100/50 mcg, 250/50 mcg and 500/50 dosage strengths for the treatment of asthma and COPD, the company said. In April 2020, Cipla announced results from a Phase 3 trial demonstrating therapeutic equivalence for the 100/50 mcg dose.
Cipla Limited Global CEO Umang Vohra commented, “We are pleased to announce the ANDA submission for generic Advair Diskus to the USFDA. 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. Our unparalleled range of offerings in this space has established our position as lung leaders in India and emerging markets and we intend to extend this offering to our developed markets.”
Read the Cipla press release.
