1. Scrip
  2. >>Therapy Areas
  3. >>Alimentary/Metabolic

FDA partially grants petitions on bioequivalence guidance for generic Pentasa and Asacol

 
• By Nancy Faigen

The US FDA opposes the idea that applicants of generic or "follow-on" formulations of extended or delayed-release oral mesalamine drug products need to show bioequivalence to ulcerative colitis treatments Pentasa or Asacol through data from comparative clinical endpoint studies. This has dampened attempts by Shire and Warner Chilcott to use the citizen's petition process to put in place such criteria.

The US FDA opposes the idea that applicants of generic or "follow-on" formulations of extended or delayed-release oral mesalamine drug products need to show bioequivalence to ulcerative colitis treatments Pentasa or Asacol through data from comparative clinical endpoint studies. This has dampened attempts by Shire and Warner Chilcott to use the citizen's petition process to put in place such criteria.

But the agency, in its joint response issued 24 August, did agree to a request of both petitioners – that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Alimentary/Metabolic

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By Joseph Haas

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.

Regeneron Buys Tirzepatide-Like Product With Eye On Muscle-Preserving Combinations

 
• By Jessica Merrill

Regeneron is bringing in its own GIP/GLP-1 agonist, establishing a path to develop proprietary obesity drug combinations with its internal muscle-sparing drugs.

A Short History Of MASH Deals, Culminating In GSK/Boston Pharma

 
• By Joseph Haas

Both high-profile failures and small investments that are yielding success so far characterize the dealmaking in MASH over the past 15 years or so.

Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 
• By Andrew McConaghie

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

More from Therapeutic Category

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By Joseph Haas

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.

Merck & Co.’s Enlicitide Poised To Be First Oral PCSK9 Inhibitor To Market

 
• By Jessica Merrill

The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.

Sanofi Cements RSV Dominance As Merck & Co. Rival Awaits FDA D-Day

 
• By Kevin Grogan

The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.