Cipla Granted Approval For First US Proventil Rival
Indian Firm Says Albuterol Shipments Will Be ‘Staggered’
Shortly after wrapping up a Phase III trial for its proposed generic Advair Diskus product in the US, Cipla has won FDA approval for the first generic Proventil HFA product, as it continues to build up steam in the US respiratory market.
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Cipla has revealed that it has now filed its ANDA for a US rival to Advair Diskus. The FDA is already considering Hikma’s generic, while Mylan’s Wixela Inhub version has been on the market for well over a year.
The agency said Cipla’s ANDA met all the requirements for approval, but also that there is increased demand for the products.
Cipla is celebrating an “important milestone” for the company after the successful completion of a Phase III clinical trial comparing its proposed Advair generic with GSK’s brand in the US. Management has cautioned that approval will be a way off yet, however.