Perrigo’s Albuterol Advantage Blunted By Recall
ProAir Rival Sees ‘Clogging’ Complaints; Cipla And Lupin Also Have Generic Albuterol
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.
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Perrigo remains unable to say exactly when it will be able to relaunch its generic to Teva’s ProAir, a position that has left the company with no choice but to impair significantly the value of the asset in the firm’s financial third quarter.
Following Perrigo’s announcement of a recall of its generic albuterol inhalers in the US, the FDA has commented on the move and has revealed that thousands of complaints have been received over the clogging problem.
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.