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Pitolisant was approved by the FDA in August 2019. [10] [11] It was granted orphan drug designation for the treatment of narcolepsy, [24] fast track designation for the treatment of excessive daytime sleepiness and cataplexy in people with narcolepsy, and breakthrough therapy designation for the treatment of cataplexy in people with narcolepsy ...
In January 2017, the FDA approved the first generic sodium oxybate product for narcolepsy symptoms, which is also subject to the same REMS program conditions as the original. [60] By April 2017, seven companies had filed Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of Xyrem, which resulted in Jazz ...
The U.S. Food and Drug Administration (FDA) approved solriamfetol based primarily on evidence from five clinical trials (Trial 1/NCT02348593, Trial 2/NCT02348606, Trial 3/NCT02348619, Trial 4/NCT02348632, Trial 5 NCT01681121) of 622 patients with narcolepsy or obstructive sleep apnea (OSA). [16]
GoodRx released a list of 19 of the most influential drugs and vaccines approved by the FDA in 2024 to treat a variety of conditions. These medications are “slated to make a big clinical impact ...
As of August 2021, an FDA-approved medication exists for IH called Xywav, which is an oral solution of calcium, magnesium, potassium, and sodium oxybates; [5] in addition to several off-label treatments (primarily FDA-approved narcolepsy medications). [6]
Adderall is also used to treat narcolepsy, ... Some medications can be used to treat PE, though they aren’t approved by the FDA (U.S. Food and Drug Administration) to treat PE specifically. ...
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