`
`APPROVAL PACKAGE FOR:
`
`~ APPLICATION NUMBER
`
`19-386/5-021
`
`Microbiology Review(s)
`
`
`
`ProductQuality Microbiology Review
`'Consult review for HFD—110
`
`22 JANUARY 2003
`
`ANDA/NDA:
`
`NDA 19-386/SCF021
`
`Name of Drug:
`
`BREVIBLOC
`
`Review Number:
`
`1
`
`Submission Date:
`
`October 24, 2002
`
`Applicant:
`
`'
`
`Baxter Health Corporation
`
`Name of Reviewer:
`
`Vinayak Pawar
`
`Conclusion:
`
`The application is recommended for
`approval
`
`lof8
`
`
`
`Microbiology Review # 1
`NDA 19-386/SCF021
`
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`2.
`
`NDA/ANDA/INDI:
`
`NDA l9-386/SCF021
`
`REVIEW NUMBER:
`
`1
`
`REVIEW DATE:
`
`22, January 2003
`
`TYPE OF SUPPLEMENT:
`
`SCF
`
`SUPPLEMENT PROVIDES FOR: a new formulation with reduced
`
`overage of active ingredients and -.
`
`~-—"—
`
`1 in place of , f“-
`
`APPLICANT/SPONSOR:
`
`Baxter Healthcare Corporation
`Name:
`Representative: Priya Jambhekar
`Telephone:
`(908)-286-72 l 5
`
`MANUFACTURING SITE: Faulding Puerto Rico Inc., Aguadilla, PR
`00604
`
`DRUG PRODUCT NAME:
`
`Brevibloc
`Proprietary:
`esmolol HCL in sodium chloride
`Non-proprietary:
`Drug Priority Classification: Standard
`
`DOSAGE FORM, ROUTE OF ADNIINISTRATION AND
`STRENGTH/POTENCY: Injectable, 10 mg/mL in 10 mL ready to use
`vials
`
`10.
`
`METHOD (S) 01“ STERILIZATION:
`
`ll.
`
`- PHARMACOLOGICAL CATEGORY:
`
`QMPWN?‘
`
`.0
`
`' DOCUMENT/LETTER DATE:
`RECEIPT DATE:
`CONSULT DATE:
`.- DATE OF AMENDMENTS:
`
`October 24, 2002
`October 25, 2002
`December 18, 2002
`NA
`
`January 7, 2003
`ASSIGNED FOR REVIEW:
`SUPPORTING/RELATED DOCUMENTS: None
`
`REMARKS: The consult requests review of NDA 19-386/SCF021 for a
`new formulation with reduced overage of active ingredients and ~
`“~-
`""‘:
`vials in place of the current
`‘..__.
`Volumes 3 and
`
`
`
`Page 2 of 8
`
`
`
`Microbiology Review # 1
`NDA 19-386/SCF021
`
`
`4 of 5 volumes were submitted for review. There are no changes in
`manufacturing process or the manufacturing controls.
`
`__—___—_———-—-————
`
`Page 3 of 8
`
`
`
`NDA 1 9-3 86/SCF02 1
`
`Microbiology Review # 1
`
`Executive Summang
`
`~I.
`
`Recommendations
`
`A.
`
`' Recommendation on Approvability -
`methOd
`The proposal to change the currently used
`adequately
`for
`-~
`of the product to
`..——-_
`assures the safety of the product Brevibloc®. The proposal is
`recommended for approval from microbiological standpoint.
`
`"‘
`
`Recommendation on Phase 4 Commitments and/or
`
`Agreements, if Approvable
`NA
`
`II.
`
`Summary of Microbiology Assessments
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology
`The changes made to the product formulation for reducing overage
`of active ingredients and addition of an isotonic agent sodium
`chloride to the product do not affect the manufacturing process.
`However, the .
`'— method has been changed from
`
`_
`_
`The
`manufacturing controls other than
`unchanged.
`
`remain
`
`----
`
`Brief Description of Microbiology Deficiencies
`None
`
`Assessment of Risk Due to Microbiology Deficiencies-
`NA
`
`III.
`
`Administrative
`
`.A.
`
`Reviewer’s Signature
`
`‘$‘
`
`B.
`
`Endorsement Block
`
`Vinayak Pawar/22, January 2003
`Peter H. Cooney/
`
`C.
`
`CC Block
`cc:
`
`Original NDA 19-386
`HFD-l 10/Division File/Melissa Robb
`
`1
`_____________—__—__——————-—-—-————————
`
`Page 4 of 8
`
`
`
`4+-
`Redacfigd
`. pégeg 6f trade
`
`usecfét and/of
`
`‘confidential
`
`:commerCial.L5
`
`infOrmation
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------.----------------.h---.I-n-—-----------------I--------..------------------.-.“-----------------
`
`Vinayak Pawar
`1/30/03 11:09:13 AM
`MICROBIOLOGIST
`
`Peter Cooney
`1/30/03 02:48:42 PM
`MICROBIOLOGIST
`
`
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