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.
You may also be interested in...
The latest update from the FDA has brought 43 new and updated product-specific guidances for generic drug development, including dedicated documents on complex generics such as aerosols, powders and sprays.
After lower growth in its India business and impaired operations at five manufacturing units hit by US FDA action impacted Lupin's third-quarter revenues, one-offs sent its net profit crashing. While deferring reinspection timelines for its Goa and Somerset plants, the company remains confident of adding at least 15 products to its US portfolio in FY21.
Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.