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Hikma’s Latest Advair Setback Pushes It Closer To Rivals

Further CRL From FDA Is ‘Minor’; Cipla Filed ANDA In May

Executive Summary

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.

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