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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Hikma has restarted launch activities for its generic version of GSK’s Advair respiratory blockbuster in the US, after the FDA gave the go-ahead following approval of an ANDA amendment.
Lannett has become the latest company to file an ANDA for a generic rival to GSK’s Advair Diskus in the US. Meanwhile, the company has revealed that it is also exploring further respiratory opportunities.
Cipla sees an incremental revenue opportunity of up to $500m for its US franchise by fiscal 2025 and expects to propel growth with strong execution of its complex generics pipeline. The company is also beginning to “lay the blueprint” in China and Brazil, it said at the J.P. Morgan Healthcare Conference.