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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A generic version of Advair is high on Cipla’s plans for its current financial year ending in March 2023. Management discussed the high-value respiratory asset and the company’s further prospects during the Indian firm’s annual earnings call, which included the company passing $1bn in sales for its domestic branded prescription business.
Cipla has provided the latest on its US complex pipeline ahead of several potential launches in the firm’s upcoming 2022/23 financial year. The Indian firm enjoyed 6% group revenue growth in Q3 FY2022 and is on track to hit its EBITDA margin target.
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.