Regulatory Update: GSK and XenoPort Submit Supplemental New Drug Application to FDA for Horizant™ in Postherpetic Neuralgia
Follow these stocks Press Release Source: XenoPort, Inc. On Tuesday August 9, 2011, 4:05 pm EDT
LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif.--(BUSINESS WIRE)-- GlaxoSmithKline (NYSE:GSK - News)(LSE:GSK.l - News) and XenoPort, Inc. (Nasdaq:XNPT - News) announced today that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults. The sNDA has been submitted to the FDA by GSK.
Notes to Editors
Horizant is not approved or licensed anywhere in the world for PHN. For information about the current licensed indication for Horizant, which is in the United States only, please visit http://www.gsk.com/products/prescription-medicines/horizant.htm for full Prescribing Information and Medication Guide.
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