FDA accepts for filing NDA for JZP 258 for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.-Jazz Pharma
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Jazz Pharmaceuticals plc announced that the FDA has granted Priority Review designation and confirmed the acceptance for substantive review of the supplemental New Drug Application (sNDA) seeking approval for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia.
Jazz Pharmaceuticals plc and the Hypersomnia Foundation announced the launch of I Have IH, a disease awareness campaign that aims to increase understanding of the debilitating sleep disorder, idiopathic hypersomnia (IH), and empower patients to recognize their symptoms and improve conversations with their care teams.
Jazz Pharmaceuticals plc announced the completion of the rolling submission for the supplemental New Drug Application (sNDA) to the FDA seeking marketing approval for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of adult patients with idiopathic hypersomnia.