Cipla Files ANDA For Advair Rival
FDA Will Now Consider Indian Firm’s Version Alongside Hikma
Cipla has revealed that it has now filed its ANDA for a US rival to Advair Diskus. The FDA is already considering Hikma’s generic, while Mylan’s Wixela Inhub version has been on the market for well over a year.
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Shortly after wrapping up a Phase III trial for its proposed generic Advair Diskus product in the US, Cipla has won FDA approval for the first generic Proventil HFA product, as it continues to build up steam in the US respiratory market.
Cipla is celebrating an “important milestone” for the company after the successful completion of a Phase III clinical trial comparing its proposed Advair generic with GSK’s brand in the US. Management has cautioned that approval will be a way off yet, however.
Hikma still sees a substantial opportunity in the generic Advair Diskus market once it makes it to market, according to CEO Siggi Olafsson, while rivals to GSK’s Ellipta range will also be coming into focus several years down the line. Meanwhile, nasal sprays gained through deals with Insys and Glenmark will aid in efforts to differentiate the firm’s non-injectables business in the US.