This is a discussion on FDA extends review of neuropathic pain drug within the Pain Management forums, part of the General Spine Discussion Forums category; FDA extends review of neuropathic pain drug. Copyright © 2009 by Custom Briefings The AP (11/10) reports that the FDA ...
FDA extends review of neuropathic pain drug FDA extends review of neuropathic pain drug.
Copyright © 2009 by Custom Briefings
The AP (11/10) reports that the FDA "needs three more months to review an application to a neuropathic pain drug being developed by XenoPort Inc. and GlaxoSmithKline PLC," called gabapentin enacarbil, according to the companies. The companies said the FDA "should complete its review of the drug" by Feb. 9, 2010. The AP adds, "The FDA wanted the companies to develop a strategy to evaluate the drug's risks, and after GlaxoSmithKline submitted that strategy, the agency needed additional time to review it." The Triangle Business Journal (11/9) also covered the story.
Justin Averna
Founder & President, Spine Patient Society™
www.SpinePatientSociety.org
A 501(c)(3) Tax-Exempt Nonprofit & Charitable Organization
I'm here to help.
- 1994: Football Injury, Severe Hyperextension
- 1997: Snow Skiing Injury
- 3/7/1997, 17 years old: Laminotomy L4/L5
- 1999 & 2003: Motor Vehicle Accidents (not at fault both times) --> Grade V Annular Tears L4/L5 & L5/L6
- 11/15/2003, 23 years old: 2-Level ProDisc® L4/L5 & L5/L6*, *lumbosacral transitional vertebra --> Dr. Rudolf Bertagnoli
- 4/2008: 4.5 years pain-free before "new" leg pain
- 5/14/2009, 29 years old: Dynamic Stabilization System L4/L5, Dr. Rudolf Bertagnoli
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justin (at) spinepatientsociety.org
Disclosure: I have no financial relationships with any surgeons, spine clinics, device manufacturers, pharmaceutical companies, hospitals, etc. -- the SPS Board of Directors serve without compensation.
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