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`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`210455Orig1s000
`
`CLINICAL MICROBIOLOGY/VIROLOGY
`REVIEW(S)
`
`
`
`DMSION OF ANTIVIRAL PRODUCTS (HFD-530)
`VIROLOGY REVIEW
`
`NDA: 210455 SDN: 000 DATE REVIEWED: May 14, 2018
`Virology Reviewer: Lisa K. Naeger, Ph.D
`
`Initial Submission Dates:
`
`Correspondence Date:
`CDER Receipt Date:
`Asslgned Date:
`Review Complete Date:
`PDU FA Date:
`
`09/22/2017
`09/22/2017
`09/22/2017
`06/13/2018
`07/20/2018
`
`Amendments:
`SDN
`002
`005
`015
`016
`017
`018
`
`Date Submitted
`10/23/2017
`11/17/2017
`(13/19/2018
`03/19/2018
`04/13/2018
`05/10/2018
`
`Date Received
`10/23/2017
`11/17/2017
`{13/19/2018
`03/19/2018
`04/13/2018
`05/10/2018
`
`Date Assigned
`11/20/2017
`11/20/2017
`03/19/2018
`03/19/2018
`04/16/2018
`05/11/2018
`
`Product Name(s)
`Proprietary: SYMTUZA
`Non-Proprietary/USAN: darunavirlcobi/emtricitabine/tenofovir alafenamide fumarate
`
`Product Name : Fixed dose combination of darunavir/oobi/emtricitabine/tenofovir alafenamide fumarate
`Darunavir
`
`
`
`
`
`
`
`
`
`
`Chemical
`
`1 .3-thiazol-5-ylmethyl[(2R. 5R)—5—{[(2$)-
`Sodium (4R,9aS)—5-Hydroxy—4-methyl—
`Name
`6.10-dioxo-3.4,6,9,9a,10-hexahydro-
`2-{(methyl{[2-(propan-2-yl)-1 ,3-thiazol-
`
`
`2H-1-oxa-4a.8a-diaza-anthracene-7-
`4-y|]methyl}carbamoyl)amino]-4—
`
`
`
`(morpholin-4-yl)butanoyIJamino}-1 .6-
`carboxylic acid
`
`
`2,4-difluoro—benz lamide
`
`
`Relative molecular mass: 547.656
`
`(active moiety) + 46.068 (ethanol.
`
`
`EtOH) = 593.724 (TMC 114»
`
`
`
`
`
`
`
`
`Molecular
`formula:
`Molecular
`
`weight
`
`Document
`
`62477
`
`No anti-HIV-1 acti '
`
`in cell culture
`
`Reference ID: 4274637
`Reference ID: 4296144
`
`
`
`DIVISION OF ANTIVIRAL PRODUCTS (HFD-530)
`VIROLOGY REVIEW
`
`DATE REVIEWED: May 14, 2018
`NDA: 210455 SDN: 000
`Virology Reviewer: Lisa K. Naeger, Ph.D
`
`Chemical
`
`
` Structure
`
`5-fluoro-1-(2R.5S)-[2-(hydroxymethyl)
`-1 ,3-oxathiolan-5-yflcytosine
`
`Molecular
`
`CstasosNaP
`
`59254 Da
`
`
`Chemical
`
`
`
`L-AIanine,N-[(S)—[[(1 R)-2-(6-amino-9H-
`Name
`purin-9-yl)-1-methyiethoxy]
`
`
`
`
`methyl]phenoxyphosphinyI]-,1-
`
`methyiethyl ester.(2E)-2-butenedioate
`
`
`1.1
`CanFNsOsS —
`
`247-24 _——
`
`NRTi NRTI
`IND 53971; NDA 21500;
`IND 63737; IND 111007
`
`
`
`
`Molecular
`
`(5)6)
`
`wa..."
`
`figflfiw
`
`Drug category: Antiviral
`Indication:
`HIV-1 infection
`
`Dosage Form/Route of administration: Fixed-dose tablet/oral
`
`The Clinical Virology Review is complete, and has been added to the NBA-210455 Multidisciplinary
`Review and Evaluation. My recommendation for this application is approval.
`
`Referen ce ID: 4274637
`Reference ID: 4296144
`
`
`
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`
`LISA K NAEGER
`
`06/07/2018
`
`JULIAN J O REAR
`
`06/07/2018
`
`Reference ID: 4274637
`Reference ID: 4296144
`
`