Harmony Biosciences announced that the U.S. FDA has approved its supplemental New Drug Application for WAKIX tablets for the treatment of excessive daytime sleepiness in pediatric patients 6 years of age and older with narcolepsy. The FDA separated the submission into two sNDAs for administrative purposes to issue an approval for the treatment of EDS and a complete response for the treatment of cataplexy in pediatric patients with narcolepsy.
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