`
`APPROVAL PACKAGE FOR:
`
`‘ APPLICATION NUMBER
`
`19-386/5-021
`
`Chemistry Review(s)4
`
`
`
`NDA 19—386/021
`
`1
`
`CHEMIST'S REVIEW ." l
`
`l. ORGANIZATION
`HFD—llO
`
`2. NBA Number
`19—386
`
` 4. Supplement(s)
`
`
`
`
`
`
`3. Name and Address oprplieant (City & State)
`Baxter Pharmaceutical Products Inc.
`
`95 Spring Street
`New Providence, NJ 07974
`
`5. Drug Name
`Brevibloc
`
`6. Nonproprietary Name
`Esmolol HCl
`
`. 8. Supplement Provides For:
`New Isotonic Formulation of Brevibloc Injection, 10 mg/mL in 10
`mL vials with reduced overage of Active Ingredient train the
`approved - ‘/o to overage -’/o (as per phase 4 commitment).
`Also this submission provides for . *‘T
`vial in place
`of the current] used . m vial.
`'
`
`
`
`
`
`
`
`
`
`
`
`
`Number(s)
`SCF-021
`
`Date(s)
`10/24/02
`
`
`7. Amendments & Other (reports,
`etc) Dates
`
`
`Amendment of 01/ 13/03
`EA Exclusion Certification.
`
`
`
`
`References: Approval letter of
`
`
`supplement #S018 of 2/ 16/01 &
`
`
`
`firm’s proposal of 9/5/01
`
`
`
`
`
`
`11. Related IND(s)/
`10. How Dispensed
`9. Pharmacological Category
`ER! DOTC
`Anti—adrener'c
`i-recetor
`NDA(s)/DMF(s)
`
`
`Type 11, DMF
`
`
`
`
`
`13.
`Potency(ies)
`12. Dosage Form(s)
`
`10 mg/mL in 10 mL ready
`Intravenous injection
`
`
`to use vials
`
`14. Chemical Name and Structure
`
`
`15. Records/Reports
`
`Current
`
`(i) methyl p—[2—hydroxy——(isopropylamino)propoxyl]
`
`EYes DNo
`hydrocinnamate hydrochloride
`
`
`
`
`Reviewed
`Molecular weight: 331.8
`C16 H25 N04 .HCl
`
`.Yes UNo
`
`
`,0
`
`
`
`H3C WOMNL
`
`0
`
`on H
`
`g esrrrolol
`
`
`
`16. Comments:
`
`
`
`
`
`Firm has provided the 3 months stability data in the ready to use new isotonic formulation containing NaCl,
`in the 10 mL vials. Firm has also provided the manufacturing formula and executed batch records of the
`three qualification batches in this supplement with reduced overage, of Brevibloc Injection 10 mg/mL in
`ready to use-10 mL vials. Firm has provided the revised labeling which reflects introduction of the isotonic
`agent, sodium chloride, USP, but immediate container label should also contain composition statement.
`Firm has now on our request, in an amendment of 01/ 1 1/03, sent the Environment Assessment Categorical
`Exclusion Certification.
`'
`
`Cont’d
`
`17. Conclusions and Recommendations
`
`This P.A.v supplement may be approved from the standpoint of chemistry. Refer also microbiological
`review of Dr. Pawar dated 01/22 /03 and draft labeling review of Dr. Shari Targum dated 01/09/03, filed
`with this supplement. The immediate container label should be revised. It should contain composition
`statement as it is in the current label.
`
`18.
`
`REVIEWER
`
`Name
`JV Advani
`
`Signature
`
`Date Completed
`Jan. 30 2003
`
`
`
`
`
`
`
`
`
`
`
`
`Distribution: EDriginal Jacket [81 Reviewer E Division File E CSO
`
`19386-021.SUP
`
`
`
`Redacyed
`
`{f-
`
`' pagegof trade
`
`Rsecfét and/of
`
`'confidential
`
`:commerCi§l_L5
`
`infOrmation
`
`
`
` nnnnnIII-II
`
`Inu-noun-I-aunnunuununn--------------------.-------------------
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`u-n-nan-unn-unuuunuuuunnuucn--—--6-.-------u--nu---------------.------n-u-u-n-n-n-n-u-n-----------nnnnnnnnnn.-
`
`/S/
`
`J. V. Advani
`
`2/14/03 06:53:31 AM
`CHEMIST
`
`Kasturi Srinivasachar
`
`2/14/03 09:05:46 AM
`CHEMIST
`
`
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