1. Generics Bulletin
  2. >>Products

AAM Commends FDA For Shelving Proposed Rule On Generic Labelling

 
• By Dean Rudge

An FDA rule proposed more than five years ago that would have allowed generic sponsors to independently update their drug labels with new information has been withdrawn. In doing so, the agency conceded the potential for “significant new burdens and liabilities” for manufacturers.

Bottles
FDA pulls proposed rule that would have let Generics players update labels independently • Source: Shutterstock

The US Food and Drug Administration (FDA) has officially withdrawn its proposed rule that would allow generic drug sponsors to independently update their product labels with new safety information, acknowledging the potential for consumer and provider confusion and a rise in generic drug costs, among other challenges.

Industry association the Association for Accessible Medicines (AAM) welcomed the action, thanking FDA Commissioner Scott Gottlieb and the agency for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Generics

US Tariff Overhang Weighs on Chinese API Exports

 
• By Dexter Jie Yan

Chinese API exports to the US fell by 24% year-on-year to $255m in May, when the US and China called a truce in a previously escalating trade war.

Cigna Claims BMS Tied Revlimid Settlements to Pomalyst ‘Pay-for-Delay’ Scheme

 
• By Dean Rudge

Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.

US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
• By Dean Rudge

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

More from Products