US FDA Generic Drug Approvals, Other Actions Declined As Approval Times Climbed In FY 2024

An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.

Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medication.
The FY 2024 generic drugs activity data likely will inform user fee reauthorization negotiations, which will begin in 2025. • Source: Alamy

More from Regulation

More from Generics Bulletin

‘Cannot Have It Both Ways’: AAM Fights MSN’s Corner In Entresto Patent Revival Appeal

 
• By 

The US Association for Accessible Medicines says it is looking to “protect the public’s interests in ensuring that patents do not let inventors control more than they invented,” as it moved to file in support of MSN Laboratories’ legal tussle with Novartis over a key patent shielding the originator’s $7.8bn Entresto blockbuster.

J&J Slaps Samsung Bioepis With Stelara Lawsuit In US

 
• By 

The same day as Samsung Bioepis and Sandoz launched their partnered Pyzchiva biosimilar rival to Stelara in the US, originator J&J hit the Korean developer with a lawsuit claiming that a private-label commercialization deal with a US pharmacy benefit manager violates the ustekinumab settlement that allowed the firms to launch.

NHS And Sandoz Look Into Natalizumab Switching Reports

 
• By 

The UK’s NHS and Sandoz have both told Generics Bulletin that they are looking into reports from a single UK hospital of adverse reactions linked to patients that have switched from Tysabri to Sandoz’s Tyruko biosimilar.