Novartis AG's Sandoz Inc. generic drug unit will not be the first to market with a generic version of GlaxoSmithKline PLC's big asthma seller AdvairDiskus (fluticasone/salmeterol) – at least not for now. Several generic drug makers are vying for the lucrative prize of being first to the US market, but the first three applications to reach the FDA for review have each been met with a complete response letter.
Three Strikes For Generic Advair With An FDA CRL For Sandoz
Novartis' generic drug unit confirmed the receipt of a complete response letter from the US FDA for a generic version of GlaxoSmithKline's Advair, following similar CRLs for Mylan and Hikma.
More from Generics
• By
After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.
• By
The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.
• By
Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.
• By
As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.
More from Products
• By
Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.
• By
Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.
• By
Generics Bulletin previews the most noteworthy and anticipated events for May 2025.