The legal case was brought against Orphan Medical Inc, a subsidiary of Jazz Pharmaceuticals. Orphan Medical pled guilty to one count of felony misbranding of a pharmaceutical product. A total of approximately $20 million in civil and criminal payments will be paid over a period of five years.
“We are pleased to have resolved this matter, which arose from the actions of Orphan Medical, a company that Jazz Pharmaceuticals acquired in 2005,” said Dr Samuel Saks, Jazz Pharmaceuticals’ CEO. “Our strong commitment to compliance was instrumental in the speedy resolution of this matter.”
Xyrem (sodium oxybate) is a Schedule III pharmaceutical product approved in the US for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy.