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


Solzira NDA resubmitted

Executive Summary

GlaxoSmithKline and XenoPort resubmit their NDA for Solzira (gabapentin enacarbil) for the treatment of restless leg syndrome Jan. 9. GSK withdrew the application last November when FDA requested that data in a single study be reformatted (1"The Pink Sheet" DAILY, Nov. 10, 2008). In addition to reformatting the data, GSK also conducted a review of other clinical studies, and the filing now consists of three Phase III trials

You may also be interested in...

FDA Wants Solzira Restless Legs Data Reformatted

Filing’s content is unaffected, says GlaxoSmithKline, which withdrew the recently submitted NDA but will resubmit it “as quickly as possible.”

European CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

UK’s NICE Backs Two Microsphere Products For Liver Cancer But Says No To Another

Health technology assessment body NICE has now recommended that selective internal radiation therapy can be used on England’s National Health Service for treating advanced liver cancer.





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