approves generic version of Jazz Pharma's sleep disorder
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[January 18, 2017]
(Reuters) - The U.S. Food and Drug
Administration said it had approved the first generic version of Xyrem,
Jazz Pharmaceuticals Plc's drug to treat patients with narcolepsy, a
kind of sleeping disorder.
The approved generic is developed by Roxane Laboratories Inc, the
FDA told Reuters.
Jazz Pharma's shares, which lost about 22 percent of their value in
2016, were down 6.6 percent at $108.00 in after-hours trading on
Xyrem is the only approved treatment for both excessive daytime
sleepiness and cataplexy in patients with narcolepsy, a chronic
Cataplexy, one of the primary and the most debilitating symptoms of
narcolepsy, causes a sudden loss of muscle control, leading to
physical collapse. (http://bit.ly/2jHzIS9)
About 70 percent people with narcolepsy suffer from cataplexy, the
Xyrem generated sales of $816.4 million in the nine months ended
Sept. 30, representing about 75 percent of Jazz Pharma's net product
(Reporting by Divya Grover in Bengaluru; Editing by Maju Samuel)
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