The clinician enrolls her in a
sodium oxybate program and continues her modafinil prescription of 400 mg daily.
The $4.4 million in product revenue was highlighted by growth in Xyrem(R) (
sodium oxybate) oral solution and strong Antizol(R) (fomepizole) Injection sales.
Jazz Pharmaceuticals markets SunosiTM (solriamfetol), Xyrem (
sodium oxybate) oral solution, Defitelio (defibrotide sodium), Erwinaze (asparaginase Erwinia chrysanthemi) and Vyxeos (daunorubicin and cytarabine) liposome for injection in the U.S.
In addition, Jazz granted Amneal a non-exclusive license to make, have made and market its own generic
sodium oxybate product under Amneal's ANDA effective December 31, 2025, or earlier under certain circumstances.
- Dublin, Ireland-based international biopharmaceutical company Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration seeking revised labeling for Xyrem (
sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy and EDS in pediatric narcolepsy patients,.
The company added that FT218 is a once nightly formulation of
sodium oxybate utilising its proprietary drug delivery platform, Micropump.
Its marketed products include Xyrem (
sodium oxybate), Erwinaze (asparaginase Erwinia chrysanthemi), Prialt (ziconotide) intrathecal infusion, FazaClo (clozapine USP) HD and LD and Luvox CR (fluvoxamine maleate).
Narcolepsy is typically treated with stimulants, REM-sleep-suppressing antidepressants and, in people with severe cataplexy,
sodium oxybate (a form of gamma-hydroxybutyrate, or GHB).
And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s
sodium oxybate (Xyrem).
MIAMI BEACH --
Sodium oxybate significantly lessened daytime sleepiness and decreased frequency of sleep attacks in people with narcolepsy concurrently taking stimulants, compared with placebo, according to study findings presented at the annual meeting of the American Academy of Neurology.
The lead product for the company is Xyrem(R) (
sodium oxybate) oral solution which is the first and only approved treatment for cataplexy associated with narcolepsy.
(
sodium oxybate or [gamma] hydroxybutyrate, Orphan Medical)