Hikma’s Latest Advair Setback Pushes It Closer To Rivals
Further CRL From FDA Is ‘Minor’; Cipla Filed ANDA In May
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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Hikma has gained FDA approval for and launched its long-in-development generic version of Advair Diskus. The milestone puts it in direct competition with Viatris’ Wixela Inhub version that was launched almost two years ago, in three presentations compared to Hikma’s two.
Hikma has provided a trading update that sheds fresh light on plans for its delayed Advair generic, as well as revealing some new launches.
After a high-profile launch early this year, first-mover Perrigo has recalled its albuterol sulfate aerosol in the US following complaints of inhalers failing to dispense due to “clogging.” The firm has revealed the expected financial impact of the move as well as commenting on how long it expects the product to be off the market, during which albuterol rivals Cipla and Lupin could benefit.