active ingredient in Xyrem (for narcolepsy); positive results from 2 Phase III trials announced 11/08; positive phase III data announced 6/09; NDA submitted 12/09; positive phase III data reported 2/10; PDUFA date scheduled 10/11/2010; FDA advisory board scheduled 8/20/10; FDA advisory board in 20-2 vote decided that the drug does not provide enough benefits to outweigh risks of abuse and accidental overdose (8/10)
Brand N/A Generic sodium oxybate (JZP-6)
Company name Jazz Pharmaceuticals, UCB Product type Non-speciality
Therapeutic category CNS Key uses Fibromyalgia
Other Uses N/A Drug Class endogenous neurotransmitter and metabolite of GABA
Dosage From oral Expected Approval 2010-Q4
FDA Filing 12/09 Last Update date August 28,2010
Link to news article
Link to published data
Link to clinicaltrials.gov
Link to press releases