July 22nd 2024
A supplemental New Drug Application has been submitted to the FDA seeking approval of esketamine (Spravato) CIII nasal spray as a monotherapy for adults with treatment-resistant depression.
Approved sNDA: Wakix for Treatment of Excessive Daytime Sleepiness in Youth With Narcolepsy
June 24th 2024The FDA has approved its supplemental New Drug Application for Wakix tablets for the treatment of excessive daytime sleepiness in pediatric patients aged 6 years and older with narcolepsy.
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