News
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT 218 for patients with narcolepsy.
Avadel Pharmaceuticals plc a company focused on transforming medicines to transform lives, announced that the FDA notified the company that the review of the New Drug Application (NDA) for FT 218 is still ongoing, and action will likely not be taken in October. The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible.
In February 2021, the FDA accepted Avadel’s NDA for FT218 and assigned a target action date of October 15, 2021. The NDA submission is supported by positive data from the pivotal Phase III REST-ON study, which was completed under a Special Protocol Assessment (SPA) agreement with the FDA..
Condition: Narcolepsy
Type: drug
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