CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Am;roval Package for:
`
`APPLICA TI0N NUMBER:
`
`19-386/S005
`
`Trade Name:
`
`'Brevibloc
`
`Generic Name:
`
`_ Esmolol hydrochloride in sodium chloride
`
`Sponsor:
`
`Baxter Healthcare Corporation
`
`Approval Date: May 26, 1989
`
`Indications:
`
`- Short—Term control of heart rate in patients
`- with abnormally fast heart rhythms such as
`artrial fibrillation, atrial flutter or sinus
`
`.
`
`tachycardia.
`
`
`
`Am;roval Package for:
`
`APPLICA TI0N NUMBER:
`
`19-386/S005
`
`Trade Name:
`
`'Brevibloc
`
`Generic Name:
`
`_ Esmolol hydrochloride in sodium chloride
`
`Sponsor:
`
`Baxter Healthcare Corporation
`
`Approval Date: May 26, 1989
`
`Indications:
`
`- Short—Term control of heart rate in patients
`- with abnormally fast heart rhythms such as
`artrial fibrillation, atrial flutter or sinus
`
`.
`
`tachycardia.
`
`
`
`CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`. APPLICA TION NUMBER:
`
`19—386/8005
`
`‘
`
`CONTENTS
`
`
`
` I Reviews / Information Included in this NDA Review._l
`
`.
`
`Approval Letter
`
`A rovable Letter
`
`Labeling
`
`Medical Review(s)
`
`
`
`
`
`
`
`
`
`
`
`, Statistical Review(s)
`
`Microbiology Review(s)
`'
`Clinical Pharmacology/ Biopharmaceutics Review(s)
`
`Administrative/Correspondence Document(s)
`
`Chemistry Review(s)
`
`Pharmacology Review(s)
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICATION NUMBER:
`1 9 -3 86/S 005
`
`APPROVAL LETTER
`
`
`
`MAX 2 6 I989
`
`nan 19-386/S~065
`
`DuPont Criticni Gare
`Attengion:
`Jenn H. waterman
`1688 Bankagan Road
`Hankegan .
`IL 68985
`
`- Dear Hr. Waterman:
`
`Piease refer fie yaur June 8, 1988 supp1eménta1 new drug anp1icatian submitted '
`under saetfan 865(h)(1§ ef the Federal Food. Drug, and fiahmetic Act for
`_Brev1blac figmmnlo1 hydraehlnride) Injectian.
`-
`The suppaamufitai unplieatien provides for —————————-————; as alternate
`manufficturar of esmaTni hydreahloride.
`
`He hage.eemnfleted the review of'this supplemennal applicatfan nan 1t 1;
`agprnued‘ Bur Ietter of Daeambar 31, 1986 neta1}ed the cendfnflans relating to
`t-e appreval ef-thfis appfliention.
`
`He reminé fan that yen must cnmply with the requirements fur an approved NBA
`set fibrtfi under 21 EFR 314g86 and 314.81.
`
`sincereiy years.
`
`fyv/ s /j/6/I’°z
`
`Robert J. Hothrs. Ph.b.
`Supervisory Chemist
`.
`affine of Drug Evaluation 1
`Center for Drug Evaluation gnd Rasearch
`
`'
`
`rank.
`
`-
`
`_
`
`HFD-l 1 fl/DCunni ngham/S[1 7/89 07690'w’a‘8’6’
`
`cc,
`
`.fl.
`
`HFD1E10
`
`«1nn¢~
`
`HFn-IIO/cso
`HFD—Efl/DBIR
`urn-Ina
`HFD-232 (with labeling)
`HFD-730
`
`sh/5f18/89/1183h
`R/D initzRHolter525/12/89
`
`APPRean
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICA TION NUMBER:
`
`19-386/8005
`
`APPROVABLE ' LETTER
`
`
`
`DEC~5 19881.
`
`:1. K'-
`
`qu 19-385/5—005
`
`DuPont Critical Care
`Attention:
`John H. Waterman
`
`1600 Haukegan Road
`Haukegan,
`IL 60085
`
`Dear Mr. Waterman:
`
`l988 supplemental new drug application submitted
`Please refer to your June 8,
`under section 505(b)(l) of the Federai Food, Drug, and Cosmetic Act for
`Brevibloc.(esmoloi hydrochloride) Injection.
`
`The supplemental application provides for.-——————————-——-as an alternate
`manufacturer of drug substance esmolol hydrochloride.
`
`He have cOMpleted the review of this supplemental application.. Before the
`supplement may be approved, however, it will be necessary for a satisfactory
`establishment evaluation report of ———————-——————————
`
`Sincerely yours.
`flu IJ/C/‘K/
`
`-
`
`Robert J. Halters, Ph.D.
`'
`Supervisory Chemist
`Division of Cardin-Renal Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`«Moos Orig NEE ,
`HFD-llo
`HFD-llO/CSO
`HFD~80IDDIR
`_
`._
`A q
`I
`HFD-"O/DCunningham/ $97Z¢Lae¢,ujptézehfi
`sh/12/05/88/1091h
`<¢
`R/D init:RWolters:lZ/05/88
`
`’
`
`_
`
`‘-
`4i¥29§2;/
`l
`
`APPROVABLE
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICA TI0N NUMBER:
`
`19-386/8005
`
`CHEMISTRY REVIEW(S)
`
`
`
`CHEMIST'S REVIEW
`
`MAY HI I989
`
`!
`l
`5
`l
`!
`!
`l
`!l
`l
`
`.
`
`5-005
`
`i
`
`!2. NDA Number
`! 1. Organization
`,!
`!
`l —386
`!
`HFD — llO
`!
`!4. AF Number
`!3. Name and Address of Applicant (City & State)
`!
`!
`DuPont Critical Care, Inc.
`Supplementgsz
`£5.
`!
`1600 Naukegan Road
`! Number 5
`! Date 5
`!
`Nauke an
`IL 6
`8
`!
`l
`!7. Nonproprietary Name
`!6. Name of Drug
`!
`!
`Brevibloc
`Esmolol hydrochloride !
`! 6/8/88
`l
`l
`l
`I
`—————_—————_——.—'_——_
`'
`l8. Supplement(s) Provides For:
`I
`.
`
`———————————————— as alternate manufacturer of
`drug substance eSmolol hydrochloride.
`
`Amendments and Other!
`!9.
`(Reports, etc.) Dates!
`!
`!
`!
`I
`l
`
`I l
`
`_
`
`ll. How Dispensedllz. Related IND/NDA/DMF(s)
`I
`!lO. Pharmacological Category
`__
`'__
`!
`_
`!
`!
`Anti—adrenergic (fl—receptor)!
`/X/ RX /
`1
`.!
`________
`!
`!
`v
`!
`!l3. Dosage Form(s)
`l4. Potency<ies>
`!
`!
`!
`!
`Injection
`lOO mglmL, 250 mg/mL
`!
`E
`!
`!
`! 19 mg/mL
`!
`!
`!l5. Chemical Name and Structure
`!lé. Records & Reports
`!
`!
`!Current
`
`TC
`
`‘:l7. Comments
`
`E1 of -—-—~—-——-————— requested on 6/29/88. Acceptable on 5/l5/89.
`
`V
`
`!
`I
`
`Yes
`
`No
`_
`
`.
`
`!Reviewed
`!
`Yes
`_l
`————
`
`.
`
`No.
`———j
`
`AP
`
`I l !
`
`.l8. Conclusions and Recommendations
`
`1 l ll
`
`.
`
`
`g
`
`»
`
`-@L Kama»!
`
`l N
`
`ang 03l0c
`
`
`-
`.
`
`'19.
`REVIEWER
`.
`'
`!Name
`i nature
`'! Date Completed'
`!
`
`
`sl
`
`au«_! Ma
`
`l7 '
`
`8
`
`'Da
`e
`
`
`lDistribution _
`1_/Div. File
`L_/Reviewer
`/ Original Jacket
`
`
`
`
`CHEMIST'S REVIEW
` . Organization
`
`
`2. NBA Number
`HFD - llO
`l'— 86
`
`
`
`. Name and Address of Applicant (City & State)
`4. AF Number
`‘
`DuPont Critic-al Care, Inc.
`1600 Haukegan Road
`
`
` . Name of Drug
`Brevibloc
`
`DEC -5 £988
`
`7. Nonproprietary Name
`Esmolol Hydrochloride
`
`8. Supplement(s) Provides For:
`
`
`
`
`Amendments and Other
`
`
`_________;;_____ as alternate manufacturer of
`(Reports, etc.) Dates
`
`
`drug substance esmolol hydrochloride.
`
`
`
`
`
`l0.'PharmacologiCal Category
`ll. How Dispensed l2. Related IND/NDAIDMF(s
`Anti-adrenergic (B receptOr)
`
`
`
`127 RX [—7 o
`l4. Potency(ies)
`
`
`l00 mg/mL 250 mglmL (l0 mglmL -S—004)
`
`
`
`
`18. Conclusions and Recommendations
`
`Approvable pending satisfactory Establishement Evaluation report.
`
`
`
`
`
`Date Completed
`SignJtugeaw‘h
`
`
`I nu e
`Decemn-
`l9::
`Gnuino ham '3
`'l Original Jacket‘J1_/Reviewer
`r:_/Div. File
`Iistribution
`
`
`
` ang 0156c..-
`
`REVIENER
`
`
`
`‘
`
`
`
`
`l3. Dosage Form(s)
`Injection
`
`l5. Chemical Name m Structure
`
`Current
`
`E1 of ———————————__—_.requested on 6/29/88.
`
`
`No
`Yes
`
`
`
`Reviewed
`Yes No
`
`
` . Comments
` Currently approved manufacturers are '*T"“"‘"‘——“————"—“-————————
`and ------————-~—————-
`
`
`
` Continued on p. 2
`
`
`
`I
`
`\D
`
`
`
`Pag€(s)«.‘e‘ld
`
`
`
`.
`
`L§ _552()(4)Trade Secret / Cnfldentlal I
`
`g
`
`-
`
`_
`
`*
`
`__ § -552(b)(5)ehberat1ve Process,
`
`‘
`
`-
`
`.
`
`___.__ § 552‘)(47)raftLae-_ ;-.. { -
`
`
`I
`
`"
`
`
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