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 received another setback on its US application for a generic version of Advair following a minor complete response letter from the FDA. The resulting delay will push back the expected final response date from the agency closer to that expected by rival Cipla, which filed an ANDA earlier this year.
Lannett has partnered with China’s Respirent for a generic version of GlaxoSmithKline’s Flovent Diskus. At the same time, the US company has extended its exclusive US distribution rights for Respirent’s Advair Diskus rival from 10 years to 12 years, as Lannett remains on track to file its ANDA this calendar year.
Cipla’s generic equivalent of Migranal is the company’s first nasal spray to receive FDA approval, accompanied by 180 days of competitive generic therapy exclusivity.