FDA OrangeBook code

U-3934

TREATMENT OF NARCOLEPSY-RELATED CATAPLEXY OR EDS IN A HUMAN PATIENT WITH A ONCE-NIGHTLY GHB FORMULATION BY INITIATING TREATMENT WITH A DOSE EQUIVALENT TO 4.5 G OF SODIUM OXYBATE AND UPTITRATING IN INCREMENTS EQUIVALENT TO 1.5 G OF SODIUM OXYBATE