CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Apnroval Package for:
`
`APPLICA TI0N NUMBER:
`
`19-386/8017
`
`BreVibloc Injection 2500mg/ML and 160mg/lOmL
`v Trade Name:
`. Generic Name: Esmolol Hydrochloride
`
`'
`
`Sponsor:
`
`Baxter Pharmaceutical Products Inc.
`
`Approval Date:
`
`January 26, 2001
`
`Indications:
`'
`
`-
`
`» Short-Term control of heart rate in patients
`with abnormally fast heart rhythms such as
`artrial fibrillation, atrial flutter or sinus
`tachycardia.
`.
`‘
`
`
`
`Apnroval Package for:
`
`APPLICA TI0N NUMBER:
`
`19-386/8017
`
`BreVibloc Injection 2500mg/ML and 160mg/lOmL
`v Trade Name:
`. Generic Name: Esmolol Hydrochloride
`
`'
`
`Sponsor:
`
`Baxter Pharmaceutical Products Inc.
`
`Approval Date:
`
`January 26, 2001
`
`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 17
`
`CONTENTS
`
` ' RevieWs / Information Included in this NDA Review.
`
`fl
`
`.
`-
`. Al inroval Letter
`
`An rovable Letter
`-
`
`Labelin 1
`
`
`
`
`'
`
`.
`
`,
`
`
`
`
`
`A
`
`
`
`
`
`Medical Review s
`
`> Chemist Review s
`Pharmacolo Review s
`
`
`
`
`
`Clinical Pharmacolo 3 / Bio - ha'rmaCeuticsReview s
`'
` dministrative/Corres.ondence Document s
`A
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH'
`-
`
`»
`
`'
`
`' APPLICATION NUMBER:
`
`19-386/3017
`
`APPROVAL LETTER
`
`
`
`fc’wml{*1
`5': ‘6 DEPARTMENTOFHEALTH&HUMANSERVICES
`PublicHealthService
`a C
`'
`'
`‘l':
`at}
`Food and Drug Administration
`Rockville MD 20857
`
`V
`
`NDA 19-386/8-017
`
`Baxter Pharmaceutical Products Inc.
`
`Attention: Priya Jambhekar
`95 Spring Street
`a
`New Providence, NJ 07974
`
`Dear Ms. Jambhekar:
`
`Please refer to‘ your supplemental new drug application dated July 28, 2000, received July 31, 2000,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Brevibloc (esmOlol
`HCl) Injection, 2500 mg/10 mLand 100 mg/lOmL.
`
`This "Changes Being Effected in 30 days" supplemental new drug application provides for revised
`HPLC methods for assay and impurities in the drug substance and drug product.
`
`We have completed the review of this supplemental application, and it is approved. Please note that
`
`the proposed Specification-limit of :——- for the degradation product,
`. is unacceptably high.
`Please refer to our ‘Approvable’ letter of December 29, 2000 for NDA 19-386/S-018 and tighten the
`
`acceptance criterion for.
`in the drug product specifications.
`'
`
`.
`
`In order to facilitate validation of the regulatory methods please submit a complete methods validation
`package. At the present time, it is the policy of the Center not to withhold approval because the _
`g
`' methods are being validated. Nevertheless, we expect your continued Cooperation to'resolve any
`problems that may be identified.
`
`We remind you that you must comply with the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
`-
`
`Ifyou have any questions, call Zelda McDonald, Regulatory Health. Project Manager, at (301)
`594-5 333.
`--
`-
`'
`‘
`'
`
`2
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Kasturi Srinivasachar, Ph.D.
`
`Chemistry Team Leader, DNDC I for the
`Division of Cardio-Renal Drug Products, (RFD-110)
`DNDC 1, Office ofNew Drug Chemistry
`. Center for Drug Evaluation and Research
`
`-
`
`
`
`Kasturi Srinivaséchar
`1/26/01 04:19:05 PM
`
`
`
`CENTER FOR DRUG EVALUATION AND
`»
`RESEARCH
`
`APPLICA TION NUMBER.-
`
`19-386/5017
`
`CHEMISTRY REVIEW(S)
`
`,
`
`’
`
`
`
`-_
`
`1'
`
`.I1
`
`-
`
`. ORGANIZATION
`HFD-llO
`
`2. NDA Number
`19-386
`
`NDA19—386/017 j
`
`'
`
`3. Name and Address of Applicant (City 81: State)
`Baxter Pharmaceutical Products Inc.
`95 Spring Street
`New Providence NJ 07974
`
`-
`
`. Supplement(s)
`Number(s)
`SOP/017
`
`Date(s)
`07/28/00
`
`1
`l
`4-
`
`.
`
`5. Drug Name
`Brevibloc
`
`6. Nonproprietary Name
`EsmololHCl
`
`>
`
`. Amendments& Other (reports,
`etc) Dates
`
`8. Supplement Provides For:
`Revised HPLC methods for assay and impurities of drug substance
`and drug product and revised specifications that-include these
`revised Methods.
`
`9. Pharmacological Category
`Anti—adreneric' 1 recetor
`
`'
`
`10. How Dispensed
`Elk; Elorc
`
`11. Related-IND(s)I
`NDA(s)/DMF(s)
`
`12. Dosage Form(s)
`Intravenous injection
`
`1
`
`13.‘ Poteney(ies)
`250mymL lOmL amp
`it] m_ mL lOmL vial
`
`14. Chemical Name and Structure
`methyl p—[2—hydroxy—(isopropylamino)propoxy]
`hydrocinnzmate hydrochloride
`0“ '
`<
`> 0/\l/\
`O
`VOH ii HC]
`
`V
`
`'
`
`_
`
`15. Records/Reports
`Current
`EYes DNo
`Rev'leWed
`éYes EINo
`
`
`
`_
`
`Comments:
`.—--for drug substance that replaces 3 old analytical
`Firm has provided the single HPLC method
`'.Also
`methods for assay and impurities
`single analytical methodf—--—-'-'- 1or drag product that replaces the approved analytical method for assay
`and provides far the determination of the degradation product
`Firm has shown that these revised methods provide the equivalent results with the approved methods and
`also validated these methods for use in the release and stability testing of the drug products.
`‘
`Cont’d
`
`Conclusions and Recommendations
`The chemistry data is satisfactory. This supplement may be approved.
`
`REVIEWER
`
`' Name
`J'V Advani
`
`Signature
`
`Date Completed
`Janu . 24 2001
`
`Distribution: E Original Jacket“ Reviewer IX] Division File E CSO
`
`l9386SNC.SUPOI7
`
`
`
`
`
`'2 3: 61d
`
`2: § 5520-)(4) Trade Secret / Cnfldenual
`
`e
`
`I
`
`_* §v 552(b)(5)j Deliberéitive Pro-Cesslv f .
`
`,
`
`~
`
`.,'_;; § _ 552)(4)raft Lael .g ~
`
`
`
`-
`
`H
`
`
`
`
`
`J. V. Advani
`1/25/01 09:44:39 AM
`CHEMIST
`
`Kasturi Srinivasachar
`1/25/01 10:50:39 AM
`CHEMIST
`
`
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