Αποτελέσματα Αναζήτησης
26 Οκτ 2018 · Xyrem oral solution, CIII, is the only product approved by the U.S. Food and Drug Administration (FDA) for both cataplexy and excessive daytime sleepiness in narcolepsy in adult and pediatric patients ages 7 and older.
Please refer to your Supplemental New Drug Application (sNDA) dated October 5, 2022, received October 5, 2022, and your amendment, submitted under section 505(b) of the Federal Food, Drug, and...
The REMS for XYREM was originally approved on February 27, 2015, and the REMS for XYWAV was approved on July 21, 2020. The two drugs are subject to the same REMS, known as the XYWAV and...
3 Ιουλ 2023 · July 3, 2023. - Launches authorized generic for Xyrem® (sodium oxybate) in the U.S., representing another new complex generic product launch. - Receives U.S. FDA approval for five new complex generics in the second quarter. - Remains on track to deliver more than 30 new generic launches in 2023.
18 Φεβ 2010 · Sodium oxybate is the active ingredient in XYREM® (sodium oxybate) oral solution, approved by the FDA and marketed by Jazz Pharmaceuticals in the U.S. for the treatment of excessive daytime...
17 Ιουλ 2002 · Xyrem (Sodium Oxybate) Oral Solution Company: Orphan Medical Application No.: 21-196 Approval Date: 7/17/2002. Approval Letter (s) (PDF)
In 2016, the FDA approved Xyrem (sodium oxybate) for the treatment of fibromyalgia in adults. This marked a significant development in the management of fibromyalgia, a chronic condition characterized by widespread muscle pain, fatigue, and cognitive difficulties. A Breakthrough in 2016.
