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.
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.
Jazz Pharms` Xywav (Calcium;Magnesium:Potassium ) Receives Approval in Europe
Enforcement Report - Week of March 25, 2020
The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India Limited for Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg). It is bioequivalent to the reference listed drug product (RLD), Klor-Con Extended-Release Tablets, 8 mEq (600 mg) and 10 mEq (750 mg), of Upsher-Smith Laboratories, LLC.( Klor-Con® is a trademark of Upsher-Smith Laboratories, LLC.)
The decision by U.S. regulators to finally approve AstraZeneca’s much-delayed excess potassium drug Lokelma gives the group another new medicine launch, boosting its portfolio as it strives to offset declining sales of older products.
Teva Pharmaceuticals USA Generic Potassium Citrate Receives Approval In US
Sanofi ($SNY) is backing out of a collaboration with Ardelyx ($ARDX) that could have paid out nearly $200 million, returning a handful of candidate treatments for high phosphates in patients with kidney disease.
Strides, Torrent Pharma, Glenmark, Lupin Gain on USFDA Nod