1. Pink Sheet
  2. >>Archive

Xyrem REMS Grudgingly Approved; FDA Worries About Blocked Generics

 
• By Derrick Gingery

FDA approves a Risk Evaluation & Mitigation Strategy for Jazz Pharmaceutical’s Xyrem under protest; the agency says the single-pharmacy distribution plan for the narcolepsy treatment has the potential to block generic competitors from the market. FDA and Jazz had been working for seven years to agree to a REMS that confirms to the requirements under the FDA Amendments Act of 2007.

The Food & Drug Administration approved a Risk Evaluation & Mitigation Strategy for Jazz Pharmaceuticals PLC’s narcolepsy drug Xyrem, but not without making clear it is unhappy that the risk management plan – which includes a single-pharmacy distribution plan – has the potential to block generic competitors.

The seven-year negotiating process ended February 27 when FDA approved

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 Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet

Opuni Appointed Acting CEO Of Ghana’s FDA As Darko Leaves To Lead African Medicines Agency

 
• By Anabel Costa-Ferreira

Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.

UK HRA Working On ‘Trusted’ Path Forward To Support Simplified Informed Consent

 
• By Vibha Sharma

The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.

EU Ups Ante On Stockpiling For Crises

 
• By Francesca Bruce

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.