ZYNRELEF®（布比卡因和美洛昔康）缓释溶液的clinical review(FDA).pdfVIP

CENTERFORDRUGEVALUATIONAND

RESEARCH

APPLICATIONNUMBER:

211988Orig1s000

CLINICALREVIEW(S)

CLINICALREVIEW

ApplicationType505(b)(2)

ApplicationNumber(s)211988

PriorityorStandardPriority

SubmitDate(s)RollingReview

Part2,ClinicaldatasubmittedonOctober30,2018

ReceivedDate(s)Part2,ClinicaldatareceivedonOctober30,2018

PDUFAGoalDateApril30,2019

Division/OfficeDAAAP/OND

ReviewerName(s)ReneePetit-Scott,M.D.

ReviewCompletionDateApril29,2019

Established/ProperNameZynrelef™

(Proposed)TradeNameBupivacaineandMeloxicamextended-releasesolution

ApplicantHeronTherapeutics,Incorporated

DosageForm(s)Solution

ApplicantProposedDosing400mgbupivacaineand12mgmeloxicamsingle-dose

Regimen(s)administration

200mgbupivacaineand9mgmeloxicam,10mLsingle-dose

administration

60mgbupivacaineand1.8mgmeloxicam,10mLsingle-dose

administration

ApplicantProposed(b)(4)

Ind