1. Pink Sheet

Cymbalta for Fibromyalgia: The REMS That Wasn't

 
• By Michael McCaughan

FDA will not necessarily require a formal Risk Evaluation & Mitigation Strategy for drugs that already have mandatory consumer medication guides. That means Lilly has a freer hand to compete against Lyrica in an important new market--and now the question becomes what FDA might do to impose tighter controls on the Pfizer brand.

FDA’s approval of Eli Lilly & Co.’s Cymbalta (duloxetine) for treatment of fibromyalgia sets another precedent in the new era of Risk Evaluation & Mitigation Strategies: the agency will not necessarily seek a formal REMS for products already accompanied by mandatory medication guides.

Cymbalta received FDA approval for the new indication on June 13. Like all antidepressants, duloxetine carries a boxed warning in...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Agency Leadership

More from Pink Sheet

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.