（pitolisant 盐酸哌替利松片）的临床报告（FDA）.pdfVIP

CENTERFORDRUGEVALUATIONAND

RESEARCH

APPLICATIONNUMBER:

211150Orig2s000

CLINICALREVIEW(S)

ClinicalReview

MartineSolages,MD

NDA211150

Wakix(Pitolisant)

CLINICALREVIEW

ApplicationTypeClassIResubmission

ApplicationNumber(s)211150

SubmitDate(s)August13,2020

ReceivedDate(s)August13,2020

PDUFAGoalDateOctober13,2020

Division/OfficeDivisionofPsychiatry/OfficeofNeuroscience

ReviewerName(s)MartineSolages,MD

ReviewCompletionDateSeptember28,2020

Established/ProperNamePitolisant

(Proposed)TradeNameWakix

ApplicantHarmonyBiosciences

DosageForm(s)4.45mgand17.8mgfilm-coatedtablets

ApplicantProposedDosing17.8to35.6mgdaily

Regimen(s)

ApplicantProposedCataplexyinadultpatientswithnarcolepsy

Indication(s)/Population(s)

RecommendationonApproval

RegulatoryAction

RecommendedTreatmentofcataplexyinadultpatientswithnarcolepsy

Indication(s)/Population(s)

(ifapplicable)

CDERClinicalReviewTemplate1

Versiondate:September6,2017forallNDAsandBLAs

ReferenceID:4684172