Perrigo Rolls Out US ProAir Rival
Launches ‘Limited Quantity’ After FDA Nod And Ramps Up Production
Perrigo has received US FDA approval for a generic version of Teva’s ProAir albuterol inhaler. The firm is immediately launching a “limited quantity” but is also ramping up production with partner Catalent to meet future demand.
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Sandoz has struck a US deal to in-license both branded Proventil HFA and an authorized generic version of the albuterol sulfate product from Kindeva Drug Delivery. The deal comes after a busy year for generic versions of albuterol that have transformed the market dynamics for the respiratory treatment.
Complex active ingredients, formulations, routes of delivery, and drug-device combination products are to receive greater attention as part of attempts to facilitate competition after the US FDA awarded a $5m grant to establish a dedicated research center.
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.