Thursday, February 16, 2012

All SharePosts Relating To "Sodium oxybate"

Expert_badge Karen Lee Richards

Karen Lee Richards

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Co-Founder of the National Fibromyalgia Assn.
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FDA Says No to Sodium Oxybate Treatment for Fibromyalgia

Recently I told you that an FDA panel had recommended not approving sodium oxybate for fibromyalgia.  On Monday, the FDA agreed with the panel's decision.  They sent Jazz Pharmaceuticals, Inc., the manufacturer of sodium oxybate, a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium... Read moreChevron
posted 10/13/2010, comments (0)|
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Expert_badge Karen Lee Richards

Karen Lee Richards

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Co-Founder of the National Fibromyalgia Assn.
Our Expert |  HealthCentral Community Member
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FDA Voting on Sodium Oxybate for Fibromyalgia

A little over a month ago, I told you that an FDA panel had recommended not approving sodium oxybate for fibromyalgia.  On October 11, the FDA will make it's final decision.    Friday I received an Action Alert from the National Fibromyalgia Association asking us to help make the FDA aware of the need for this treatment... Read moreChevron
posted 10/03/2010, comments (10)|
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Expert_badge Karen Lee Richards

Karen Lee Richards

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Co-Founder of the National Fibromyalgia Assn.
Our Expert |  Living With It
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FDA Advisory Panel Nixes Sodium Oxybate for Fibromyalgia

Last Friday, members of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee overwhelmingly voted (20 to 2) against approving sodium oxybate (brand name Xyrem) for the treatment of fibromyalgia.  While most of the panel members agreed that the drug was effective for some FM patients, their concerns... Read moreChevron
posted 08/25/2010, comments (2)|
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Expert_badge Karen Lee Richards

Karen Lee Richards

(Profile)
Co-Founder of the National Fibromyalgia Assn.
Our Expert |  Living With It
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This widget is a small module that you can place on personalized sites (like iGoogle, Facebook, or your blog) and get automatic updates from our experts!   |  RSS

FDA To Consider Possible New Fibromyalgia Medication

Jazz Pharmaceuticals, Inc. has announced that the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.  The target date for the FDA to complete its review of the New Drug Application is October 11,... Read moreChevron
posted 06/29/2010, comments (0)|
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Expert_badge Karen Lee Richards

Karen Lee Richards

(Profile)
Co-Founder of the National Fibromyalgia Assn.
Our Expert |  Living With It
Get Widget TooltipGet Widget
This widget is a small module that you can place on personalized sites (like iGoogle, Facebook, or your blog) and get automatic updates from our experts!   |  RSS

Xyrem Seeks FDA Approval for Treating Fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application to the FDA for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.  Sodium oxybate is currently marketed as Xyrem and is thus far only approved for the treatment of excessive daytime sleepiness and cataplexy associated with narcolepsy.  The... Read moreChevron
posted 12/21/2009, comments (0)|
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