ghb
terrasig | February 19, 2010Just a quick post on an article that caught my eye: Jazz Pharmaceuticals of Palo Alto, CA, has announced that the US FDA has accepted their new drug application (NDA) filing for JZP-6, or sodium oxybate, for the treatment of pain and fatigue associated with fibromyalgia.
The NDA was based on positive outcomes of two, Phase III clinical trials - those randomized, placebo-controlled double-blind trials that serve as the gold standard for drug efficacy. The company expects an approval decision from FDA by October 2010.
Jazz has already garnered approval for sodium oxybate under the brand name…