Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Xyrem REMS Grudgingly Approved; FDA Worries About Blocked Generics

This article was originally published in RPM Report

Executive Summary

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.

You may also be interested in...



Sharing Information With US FDA Advisory Committee Can Invalidate Patent, Jazz Finds

Federal Circuit rules that material about Xyrem's REMS distribution system provided for advisory committee review constitutes prior art.

REMS Lawsuit Possible After US FDA Approves Generic Xyrem

FDA waives requirement that Roxane's generic use same REMS as the brand; Jazz ‘intends to evaluate all potential challenges.’ Launch of generic still depends on patent litigation.

REMS Lawsuit Possible After US FDA Approves Generic Xyrem

FDA waives requirement that Roxane's generic use same REMS as the brand; Jazz ‘intends to evaluate all potential challenges.’ Launch of generic still depends on patent litigation.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS079827

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel