`
`Approval Package for:
`
`APPLICA TI0N NUMBER:
`
`19-386/5011
`
`Trade Name:
`
`Brevibloc 100 mg/ 10 ml Vial
`
`Generic Name: Esmolol Hydrochloride
`
`Sponsor:
`
`Anaquest Inc.
`
`Approval Date: November 24, 1993
`
`Indications:
`I
`
`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 Supplement 11
`
`CONTENTS
`
`
`
`'EReviews / Information Included in this NDA Reviewj
`
`A roval Letter
`
`A n in rovable Letter
`Labelin_
`'
`
`Medical Review s
`
`Chemist Review s
`
`Pharmacoloa Review s
`Statistical Review s
`
`Microbiolo Review s
`
`Clinical Pharmacolo 3 / Bio harmaceutics Review s
`Administrative/Cones n ondence Document s
`
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH ‘
`
`APPROVAL PACKAGE FOR:
`
`APPLICATION NUMBER
`
`NDA 19-386/5-011
`
`Approval Letter(s)
`
`
`
`I
`7
`NDA 19-386/8-011
`
`ya!
`$4965 0
`
`J
`
`1/
`
`<30
`
`Anaquest Inc.
`Attention: Robert I. Outwater
`110 Allen Road
`'
`PO. Box 804
`
`Liberty Corner, NJ 077938-0804
`
`Dear Mr. Outwater:
`
`NOV 2 4 [993
`
`,
`
`Please refer to your Novembe1 5 1993 supplemental new d1ug application submitted under
`section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act for Brevibloc (esmolol HCl)
`Injection.
`.
`
`’
`
`.for the amber
`The supplemental application provides for the substitution of a clear
`vial presently used for the 10 mL single dose vial of Brevibloc Injection (100 mg/vial).
`We have completed the review of this-supplemental application and it is approved.
`
`
`
`We remind you that you must comply with therequirements for an approved NDA set forth
`under 21 CFR 314.80 and 314.81.
`
`Sincerely yours
`
`W /1 ”5/73
`
`Robert}. Wolters, Ph. D.
`
`Supervisory Chemist
`Division of Cardio—Renal Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`c0'
`
`"®
`
`'
`
`HFC-‘lBO/IAllen
`111315—110
`‘
`
`-
`
`HFD-llO/CSO
`HFD-80/DDIR
`
`-
`HFD-IOO‘
`HFD232 (With labeling)
`_ HFD-730
`
`HFD—llO/DCunningham/l 1/18/93;11/23/93 WWWZWF 1/22/
`
`93,
`
`clb/11/23/93/N19386 S11.
`R/D init: RWolters/11/22/93
`
`Approval Date: December 31, 1986
`
`APPROVAL
`
`
`
`CENTER" FOR DRUG EVALUATION: AND RESEARCH
`
`APPROVAL PACKAGE FOR:
`
`APPLICATION NUMBER
`
`NDA 19-386/5-011,
`
`Chemistry Réview(s) -
`
`
`
`CHEMIST'S REVIEW‘
`
`NOV, 2 4 $93
`
`2. NBA Number ,
`19-386
`
`6. Nonproprietary Name
`Esmolol h drochloride
`
`-
`
`
`
` 4. Supplement(s)
`1.
`ORGANIZATION
`HFD-11O
`3. Name and Address of Applicant (City a State)
`
`
`
`Number(s)
`Date(s)
`Anaquest Inc.
`
`
`110 Allen Road
`
`
`
`P,0. Box 804
`11/5/93
` s—011
`(CS)
`Liberty Corner, NJ 07938—0804
`
`
`8. Amendments &
`5. Drug Name
`
`
`Brevibloc
`other (reports,
`
`etc) - Dates
`
`
`
`7. Supplement Provides For:
`Substitution of a clear —-—‘—‘——”‘for the
`.amber vial presently utilized for the 10 mL
`single dose vial of Brevibloc (esmolol Hcl)
`injection (100 mg esmolol HCl/vial).
`
`
`
`
`10. How Dispensed
`9; Pharmacological Category
`
`
`
`
`11. Related IND(s)/
`Anti-adrenergic (fl—receptor)
`NDA(s)/DMF(s)
`
`
`
`
`[Em [:IOTC
`
`
`
`
`12. Dosage Form(s)
`
`
`_13. Potency(ies)
`
`'250mg/mL lOmL amp.Intravenous injection
`
`10 mg/mL lOmL vial
`
`1S. Records/Reports
`
`14. Chemical Name and Structure'
`Current
`
`EYES
`ENG
`Reviewed
`
`
`[:JYes:
`ENC
`16. Comments:
`
`There are no changes in the formulation,
`
`of the manufacture.
`
`
`processing methods, the site
`
`
`
`
`
`cont'd
`
`17. Conclusions and Recommendations:
`
`
`AP. There was no change in formulation or manuf_acturing site, only
`the color of the vial.
`
`
`
`
`The amber glass‘vial currently used was chosen to differentiate the
`product from 250 mg/mL 10 mL colorless vial ‘————-——— This
`differentiation is no longer necessary since only two dosage forms
`are manufactured:
`10 mg/mL, 10 mL vial and 250 mg/mL ampule.
`
`Apparently the 250 mg/mL strength will be packaged in ampules only.
`
`I
`
`'
`
`19386611.SUP
`
`Date Completed
`November 18, 1993
`
`
`
`I
`
`' \
`
`,
`
`. 36(8) -
`
`
`
` .:
`
`,61"
`
`I
`
`A§ 552()(4)'TradeS€Cfet/ C 1dent1a1 I
`
`1
`
`'
`
`_
`
`._ § - 552(b)(5) Dehberatlve PrO-CESS .-
`
`_
`
`V
`
`'
`
`-
`
`'
`
`
`
`
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