斑蝥素（cantharidin)外用制剂的ND审评（CDER）.pdf

CENTERFORDRUGEVALUATIONAND

RESEARCH

APPLICATIONNUMBER:

212905Orig1s000

MULTI-DISCIPLINEREVIEW

SummaryReview

ClinicalReview

Non-ClinicalReview

StatisticalReview

ClinicalPharmacologyReview

CLINICALREVIEW

NDA#:212905,Class2resubmission

SubmissionDate:23January2023

StudyName:VP-102

BrandName:Ycanth(conditionallyapproved)

GenericName:cantharidin

DosageForm:Topicalsolution

DosageStrength:0.7%

Reviewer:MaryKim,M.D.

TeamLeader:AmyWoitach,D.O.,M.S.

DivisionDirector:ShariTargum,M.D.

RegulatoryProjectManager:QianyirenSong,PharmD

Center:CenterforDrugEvaluationandResearch

Office:OfficeofNewDrugs,OfficeofImmunologyandInflammation

Division:DivisionofDermatologyandDentistry

Sponsor:VerricaPharmaceuticalsInc

SubmissionType:ResponsetoaCompleteResponseAction

IndicationSought:ForthetreatmentofMolluscumcontagiosuminpatients2years

andolder

Subject:ClinicalReviewofNDA212905ThirdResubmissionafter

ThirdCompleteResponse

DateinDARRT