Jazz Pharmaceuticals Inc.

Palo Alto, CA: (Jul-13-07) The Department of Justice, the US Attorney's Office for the Eastern District of New York, the Office of the Inspector General of the United States Department of Health and Human Services, the United States Office of Personnel Management, and the United States Department of Tricare Management Activity brought charges against Jazz Pharmaceuticals Inc., alleging that the company misbranded a pharmaceutical product by its subsidiary, Orphan Medical Inc. The investigation centered on promotion of Xyrem, a pharmaceutical product approved in the United States for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy. Investigators said some Orphan employees conspired to defraud the United States with the goal of expanding the market for Xyrem by promoting the drug for off-label indications that included chronic pain, weight loss, depression, bipolar disorder, fibromyalgia, insomnia, movement disorders such as Parkinson's disease, fatigue, and EDS not associated with narcolepsy. In a settlement reached, the Palo Alto-based company agreed to pay about $20 million over five years to the government agencies. [MSN NEWS: OFF-LABEL XYREM]

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Published on Jul-16-07