Enforcement Report - Week Of June 01, 2022
DUBLIN, Jan. 3, 2022 /PRNewswire/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) for Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, for the treatment of idiopathic hypersomnia in adults, making it the second ODE for the medication following the exclusivity granted in the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
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DUBLIN, Oct. 20, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the publication of the global Phase 3 double-blind, placebo-controlled, randomized-withdrawal, multicenter study of Xywav™ (calcium, magnesium, potassium and sodium oxybates) oral solution, for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. The results were published in SLEEP, the peer-reviewed, international journal of the Sleep Research Society.
DUBLIN, Aug. 27, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that 10 abstracts will be presented at Virtual SLEEP 2020, the 34th annual meeting of the Associated Professional Sleep Societies (APSS) from August 28-30. The presentations will debut data across Jazz's neuroscience therapeutic area, featuring important new insights into the company's ongoing sleep medicine research.
Jazz Pharms` Xywav (Calcium;Magnesium:Potassium ) Receives Approval in Europe
The purpose of this study was to develop the novel naproxen/esomeprazole magnesium compound pellets (novel-NAP/EMZ) depending on EMZ acid-independent mechanism which has been proved to be predominate in the mechanism of co-therapy with nonsteroidal anti-inflammatory drug. The novel-NAP/EMZ compound pellets, composed of NAP colon-specific pellets (NAP-CSPs) and EMZ modified-release pellets (EMZ-MRPs), were prepared by fluid-bed coating technology with desired in vitro release profiles. The resulting pellets were filled into hard gelatin capsules for in vivo evaluation in rats and compared with the reference compound pellets, consisted of NAP enteric-coated pellets (NAP-ECPs) and EMZ immediate-release pellets (EMZ-IRPs).
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