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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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.
The market for generic albuterol sulfate is becoming increasingly commoditized in the US, with Lupin announcing FDA approval for generic ProAir – the Indian company’s first device-based inhalation product in the US. Nevertheless, it remains a lucrative opportunity for ANDA sponsors.