Scrip 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


FDA questions preclude approval of GSK/Valeant's anti-epileptic Potiga

This article was originally published in Scrip

Executive Summary

GlaxoSmithKline and Valeant Pharmaceuticals have taken another hit in their bid to gain USFDA approval for their anti-epileptic Potiga (ezogabine), as the companies said the regulator had provided a complete response letter and declined to approve the NDA for the product in its current form for unspecified "non-clinical" reasons.


Related Companies




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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