Posts tagged ‘fibromyalgia’

XYREM – PDUFA Date

October 11, 2010 is the PDUFA Date for Jazz Pharmaceuticals’ (JAZZ) XYREM for the fibromyalgia indication.  The drug is currently approved for narcolepsy.  Jazz  presented the XYREM fibromyalgia data to the FDA Advisory Committee on August 20, 2010 and did not receive a positive recommendation from the Committee.  The Committee rejected their REMS proposal 20-2.  It is unlikely the deficiencies in the REMS will be overcome by October 11, 2010.