- CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Apgroval Package for:
`
`APPLICA TION NUMBER:
`
`19-3186/8015
`
`Trade Name:
`BreviblOc Injection 2500mg/ML and 100mg/10mL
`_‘ Generic Name: Esmolol Hydrochloride
`1
`
`Sponsor:
`
`. Baxter Pharmaceutical Products inc.
`
`Approval Date: February 23, 2000
`
`Indications:
`
`ShOrt—Term control of heart rate in patients
`with abnormally fast heart rhythms such as
`artrial fibrillation, atrial flutter or sinus '
`tachycardia.
`'
`‘
`
`
`
`Apgroval Package for:
`
`APPLICA TION NUMBER:
`
`19-3186/8015
`
`Trade Name:
`BreviblOc Injection 2500mg/ML and 100mg/10mL
`_‘ Generic Name: Esmolol Hydrochloride
`1
`
`Sponsor:
`
`. Baxter Pharmaceutical Products inc.
`
`Approval Date: February 23, 2000
`
`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/Supplement 15
`
`CONTENTS
`
`
`
`ReViews / Information Included in this NDA Review.
`
`
`
`
`
`
`
`
`
`Approval Letter
`
`Approvable Letter
`7.
`.
`.
`' Labeling
`_
`
`
`
`
`
`
`
`'
`
`_
`
`
`
`
`'
`
`>
`
`
`Chemistry Review(s)
`
`Pharmacology Review(s)
`
`
`Statistical Review(s)
`
`,
`Microbiology Review(s)
`
`
`Clinical Pharmacology/ Bioph‘armaceutics Review(s
`
`
`
`
`
`Administrative/CorrespOndence Document(s)
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`
`. RESEARCH -
`
`APPLICATION NUMBER:
`19-386/8015
`
`’ APPROVAL LETTER
`
`
`
`FEB 23 2000
`
`NBA 19-386/S-015
`
`Baxter Pharmaceutical Products Inc.
`Attention: Ms. Priya Jambhekar
`95 Spring Street
`New Providence, NJ 07974
`
`Dear Ms. Jarnbhekar:
`
`Please refer to your August 26, 1999 supplemental new drug application submitted under section
`505 (b) of the Federal Food, Drug, and Cosmetic Act for Brevibloc (esmolol HCL) Injection,
`2500 mg/lO mL and 100 mg/IO mL.
`-
`
`The supplemental application provides for new alternative testing laboratories (Baxter
`Pharmaceutical Products, Inc,., Memphis, TN and Baxter Healthcare Corporation, Cleveland,
`MS) for release and stability testing of the drug product.
`
`We have completedvthe review ofthis supplemental application and it is approved.
`
`We remind you that you must comply with the requirements. for an approved NDA set forth
`under 21 CFR314.80 and 314.81.
`'
`
`Sincerely yours,
`
`K ,‘L-nxuaalw I 2—1341)
`
`»
`Kasturi Srinivasachar, Ph.D.
`Chemistry Team Leader, DNDC I
`Division of Cardio-Renal Drug Products (HFD—l 10) ,
`Office of New Drug Chemistry
`'
`Center for Dmg'Evaluatibn and Research
`
`
`
`NDA 19-386/Sj015 - Page 2
`
`CC:
`
`-
`
`Original NDA 19-386/8—01 5
`HFD-i 10/Division File
`HFD-l IO/Proj ect Manager
`HFD-l 10/JAdvani
`HFD-95
`
`DISTRICT OFFICE
`HFD-8 lO/Jsimmons
`
`Init. by: Ksrinivasachar
`Drafted by: SO/2/23/00
`
`' Approval Date: 12/31/86
`
`APPROVAL
`
`
`
`. CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICA TION NUMBER:
`
`19-386/8015
`
`CHEMISTRY REVIEWQS)
`
`
`
`-
`
`-
`
`CHEMIST'S REVIEW
`
`.
`
`1. ORGANIZATION
`HFD-llO
`
`JAN 3 " 2000
`
`3. Name and AddreSs of Applicant (City a State)
`Baxter Pharmaceutical Products Inc.
`95 Spring Street
`Y
`' New Providence NJ 07974
`
`4. Supplement(s)
`Number(s)
`Date(s)
`SCH-015
`8/26/99
`
`'
`
`Brevibloc
`
`6. Nonprcprietary'xame
`Esmolol HCl
`g
`
`_
`7. Amendments I'- other
`(reports, etc) - Dates
`
`8. Supplement Provides For:
`finnlflfiflflMl following laboratories for
`conducting release and/or stability testing
`of finished uroductr
`'
`-
`
`‘9. Pharmacological Category
`Ant i—adrenergic
`([3
`receftor
`
`l2. Dosage Form(s)
`Intravenous injection
`
`10. How Dis ensed
`Elm:
`o'rc
`
`11. Related INDts)/
`NDA(s) /DMF(s)
`.
`
`13. Potency(ies)
`250mg/mL lOmL amp
`10 mg/mL lOmL
`vial
`
`,
`14._Chemical-Name-and Structure
`methyl p—[2—hydroxy-(isopropylamino)propoxy]
`hydrocinnamate hydrochldride
`
`15. Records/Reports
`Current
`'
`Eye;
`Duo
`
`Reviewed
`ates
`
`Duo
`
`
`
`'16. Comments
`
`Prior Approval Supplement
`
`The analytical testing will be conducted at:
`Baxter Pharmaceuticals Products Inc.
`1710 N. Shelby Oaks Drive, Suite 1—6
`Memphis, TN 38134-7402
`'
`
`The microbial testing will be conducted at:
`Baxter Healthcare Corporation
`IV Systems and Medical Products
`911 North Davis
`Cleveland, MS 38732
`
`GMPs certificates are included.
`
`17. Conclusions and Recommendations
`_EER requested on 9/3/99.
`Inspection will not be done before 12/30/99 (see attached memo) and because
`this is the only CMC issue for this supplement the"4ffi6fitfi“§6§lmaatémfi111”
`not be met.
`'
`‘
`'
`
`' Danute G. Cunnin-ham
`
`.,_ .
`
`-
`
`'
`
`lgyflaflugfl December 14
`
`1999
`
`‘
`
`Distribution:
`
`E] Original Jacket E] Reviewer E] Division File [3 C50
`
`1938315.SUP
`
`_
`
`-
`
`.
`K W—
`
`
`
`CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`-
`
`APPLICATION NUMBER:
`19-386/8015
`
`ADMINISTRATIVE and CORRESPONDENCE-
`'
`DOCUMENTS .
`~
`'
`
`
`
`FEB 2 3 2000
`
`MEMORANDUM
`
`Date:
`
`23 FCb. 2000
`
`..
`
`From: K. Srinivasachar, Ph.D., Chemistry Team Leader, I-IFD-l 10
`
`1’[JAudi-410V Z ’23—00
`
`To:
`
`. NDA 19-386, Brevibloc (esmolol HCl) Injection
`
`Subject: Addendum to Chemistry Review dated 14 Dec 1999 by D. Cunningham for SCM—OIS -
`
`The EER for the 2 facilities listed was completed on 8 Feb 2000 with an overall Acceptable
`recommendation. Since this was the only pending issue the Supplement may now be approved.
`
`Conclusions and Recommendations: Issue Approval letterfor SCM-OlS.
`
`CC:
`
`Orig. NDA 19-3 86
`HFD—l 10/ Div. File NDA 19-386
`RFD-1107 K. Srinivasachar/Project Manager/J.Advani
`
`
`
`23-FEB-2ooo’
`
`FDA CDER EES
`
`ESTABLISHIVIENT EVALUATION REQUEST
`SUMMARY REPORT
`
`Page
`
`'
`
`1 of
`
`'
`
`'
`NDA 19386l015
`Application:
`Stamp: 30—AUG-1999 Regulatory Due: 30-DEC-1999
`Applicant:
`BAXTER PHARM PROD
`'
`110 ALLEN RD
`LIBERTY CORNER, NJ - 079380804
`
`'
`
`Org Code: 110
`Priority: 1P
`District Goal: 25-Nov—1999
`Action Goal:
`BREVIBLOC (ESMOLOL HCL) INJ
`Brand Name:
`Established Name:
`'
`Generic Name: ESMOLOL HYDROCHLORIDE
`Dosage Form: I
`INJ
`(INJECTION)
`Strength:
`250 MGIML AND 10 MG/ML
`
`FDA Contacts:
`ID = 100846
`, Review Chemist
`K. SRlNIVASACHAR (RFD-110) 301-594-5376 , Team Leader
`
`
`
`Overall Recommendation:
`
`
`ACCEPTABLE on 08—FEB-2000 by J. D ANIBROGIO (HFD-324)301-827-0062
`
`Establishment: 1041673
`
`.
`
`DMF No:
`
`BAXTER (PPI) DISTRIBUTION CENT] AADA'NO:
`. 1710 N. SHELBY OAKS DRIVE, SUITE
`MEMPHIS, TN 38134-740
`-
`
`OAI Status: NONE
`:CTL ‘
`Profile:
`Last Milestonez' OC RECOMMENDATION
`Milestone'Date: 21-JAN-2000
`Decision:
`ACCEPTABLE
`
`DISTRICT RECOMMENDATION
`
`Reason:
`
`‘
`
`_
`
`‘
`
`Responsibilities: FINISHED DOSAGE RELEASE
`TESTER
`'
`ggggib DOSAGE STABILITY
`-
`
`Establishment: 1019003
`BAXTER HEALTHCARE CORP ‘
`91 1 N DAVIS
`
`DMF No:
`AADA No:
`
`CLEVELAND,MS 313732
`
`0A1 Status: NONE
`Profile: CTL
`Last Milestone: oc RECOMMENDATION-
`Milestone Date: osmEmooo
`Decision: -'
`ACCEPTABLE
`
`Reason:
`
`,
`
`DISTRICT RECOMMENDATION
`
`- Responsibilities: FINISHED DOSAGE 'STERILI'I'Y
`'
`,
`_ TESTER
`
`'
`
`
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