LONDON, RESEARCH TRIANGLE PARK, N.C., and ALISO VIEJO, Calif.,
Aug. 30 /PRNewswire-FirstCall/ — GlaxoSmithKline (NYSE:
GSK) and Valeant Pharmaceuticals International (NYSE:
VRX) announced today the U.S. Food and Drug Administration
(FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal
date for ezogabine* to 30 November 2010. The original goal
date was 30 August 2010.
The FDA has not yet completed the review of the New Drug
Application (NDA) for ezogabine due to the recent submission of a
formal REMS (Risk Evaluation and Mitigation Strategy) for
ezogabine, an investigational anti-epileptic drug being studied for
the adjunctive treatment of adults with partial onset seizures. The
REMS was requested by FDA in correspondence dated 16 August 2010
and submitted to the FDA on 26 August 2010.
The NDA was submitted to the FDA on 30 October 2009. The
companies will continue to work closely with FDA as the Agency
completes its review.
GlaxoSmithKline – one of the world’s leading
research-based pharmaceutical and healthcare companies – is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For further
information please visit www.gsk.com
Valeant Pharmaceuticals – Valeant Pharmaceuticals
VRX) is a multinational specialty pharmaceutical company that
develops, manufactures and markets a broad range of pharmaceutical
products primarily in the areas of neurology and dermatology.
More information about Valeant can be found at www.valeant.com.
GlaxoSmithKline cautionary statement re