“In July 2007 Jazz and their subsidiary Orphan Medical pleaded guilty to a criminal charge of felony misbranding in their marketing of sodium oxybate; they also settled a civil suit at the same time. The matter had been raised by a former sales representative who filed a qui tam case against the company under the False Claims Act. Sales representatives had made sales calls to doctors who did not treat people with narcolepsy and told them about potential uses for the drug including fatigue, insomnia, chronic pain, weight loss, depression, bipolar disorders, and movement disorders like Parkinson’s Disease, and downplayed the risks described in the label's black box warning. A sales manager who had been involved in the illegal marketing scheme had previously pleaded guilty and a psychiatrist who promoted the drug had previously been charged. Jazz paid $20M in total and agreed to a corporate integrity agreement and to implement internal reforms.[9][40][41]
The FDA sent Jazz an FDA warning letter about safety violations in September 2007.[42]
In 2010 the FDA rejected Jazz' New Drug Application for use of sodium oxybate in fibromyalgia.[43]
In October 2011, the FDA sent Jazz another FDA warning letter for failing to collect, evaluate, and promptly report adverse effects to the FDA after it started marketing the drug.[42] It sent another letter in 2013 saying that the problems described in the 2011 letter appeared to be resolved.[44]”
https://en.m.wikipedia.org/wiki/Sodium_oxybate
The FDA sent Jazz an FDA warning letter about safety violations in September 2007.[42]
In 2010 the FDA rejected Jazz' New Drug Application for use of sodium oxybate in fibromyalgia.[43]
In October 2011, the FDA sent Jazz another FDA warning letter for failing to collect, evaluate, and promptly report adverse effects to the FDA after it started marketing the drug.[42] It sent another letter in 2013 saying that the problems described in the 2011 letter appeared to be resolved.[44]”
https://en.m.wikipedia.org/wiki/Sodium_oxybate