`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`205029Orig1s000
`
`MICROBIOLOGY / VIROLOGY REVIEW(S)
`
`
`
`
`
`
`
`
`
`
`
`
`Product Quality Microbiology Review
`2/04/2013
`
`NDA 205029
`
`Drug Product Name
`Proprietary:
`
`Non-proprietary: Epinephrine Injection, USP
`
`
`Review Number: 1
`
`
`Dates of Submission(s) Covered by this Review
`Submit
`Received
`Review Request
`12/04/2012
`12/04/2012
`12/17/2012
`2/04/2013
`2/04/2013
`N/A
`
`Assigned to Reviewer
`12/20/2012
`N/A
`
`
`
`Submission History (for amendments only): None
`
`Applicant/Sponsor
`Name: Belcher Phamaceuticals, LLC
`Address: 6911 Bryan Dairy Road, Suite 210, Largo FL 33777
`Representative: Mihir Taneja
`Telephone: 727-471-0850 Ext. 250
`
`
`Name of Reviewer: Steven P. Donald, M.S.
`
`Conclusion: Recommended for Approval
`
`
`
`
`Reference ID: 3262531
`
`(b) (4)
`
`
`
`NDA 205029
`
`Microbiology Review #1
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`TYPE OF SUBMISSION: Original NBA
`
`SUBMISSION PROVIDES FOR: Manufacture and marketing of a
`sterile drug product.
`
`MANUFACTURING SITE: Sintetica S.A., Via Penate, 5 CP 1764,
`
`Mendrisio, Switzerland CH-6850
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY: Sterile solution for injection, intravenous, 1
`mg/ml in glass ampoules
`METHOD(S) OF STERILIZATION:—
`
`PHARMACOLOGICAL CATEGORY: Adrenergic agonist
`
`
`
`B.
`
`C.
`
`SUPPORTING/RELATED DOCUMENTS: DIVIF
`
`E inc brine,
`
`LOA omfl
`
`dated 9/13/2012 is provided for reference to the manufacture of the
`drug substance.
`
`REMARKS: An information request was sent to the sponsor on 1/23/2013 and a
`response was received on 2/04/2013. The additional information provided is
`included in this review.
`
`filename: N205029rl .doc
`
`Reference ID: 3262531
`
`Page 2 of 15
`
`
`
`NDA 205029
`
`Microbiology Review #1
`
`Executive Summary
`
`I.
`
`Recommendations
`
`A.
`
`Recommendation on Approvability —
`NDA 205029 is recommended for approval.
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable -
`
`II.
`
`Summary of Microbiology Assessments
`
`A.
`
`B.
`
`Brief Description of the Manufacturin Processes that relate to
`Product Quali Microbiolo
`
`
`
`Brief Description of Microbiology Deficiencies— No product
`quality microbiology deficiencies were identified based upon the
`information provided.
`
`C.
`
`Assessment of Risk Due to Microbiology Deficiencies - None.
`
`III.
`
`Administrative
`
`A.
`
`B.
`
`Reviewer's Signature
`
`Endorsement Block
`
`C.
`
`CC Block
`
`N/A
`
`Steven P. Donald, M.S.
`
`Stephen Langille, Ph.D.
`Senior Microbiology Reviewer
`
`Pa e 3 of 15
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`STEVEN P DONALD
`02/15/2013
`
`STEPHEN E LANGILLE
`02/15/2013
`
`Reference ID: 3262531
`
`
`
`PRODUCT QUALITY MICROBIOLOGY FILING CHECKLIST
`
`NDA Number: 205029
`
`Applicant: Belcher
`Pharmaceuticals LLC
`
`Letter Date: 12/04/2012
`
`Drug Name: Epinephrine
`Injection USP
`
`NDA Type: 505 (b)(2)
`
`Stamp Date: 12/04/2012
`
`The following are necessary to initiate a review of the NDA application:
`
`H.
`
`Content Parameter
`
`Is the product quality microbiology information described
`in the NDA and organized in a manner to allow substantive
`review to begin? Is it legible, indexed, and/or paginated
`adequately?
`
`Has the applicant submitted an overall description of the
`manufacturing processes and microbiological controls used
`in the manufacture of the drug product?
`
`Has the applicant submitted protocols and results of
`validation studies concerning microbiological control
`processes used in the manufacture of the drug product?
`
`Are any study reports or published articles in a foreign
`language? If yes, has the translated version been included
`in the submission for review?
`
`Has the applicant submitted preservative effectiveness
`studies (if applicable) and container-closure integrity
`studies?
`
`3-2.P.3.32
`Description of
`Manufacturing
`Process
`
`3.2:P.3:52 Process
`vahdation
`
`\I
`
`Has the applicant submitted microbiological specifications
`for the drug product and a description of the test methods?
`
`3-2-P_-5-11 _
`Specifications
`
`Has the applicant submitted the results of analytical method X
`verification studies?
`
`3-2-P-5-23 Analytical
`Procedures
`
`Has the applicant submitted all special/critical studies/data
`requested during pre-submission meetings and/or
`discussions?
`
`1‘”A
`
`If sterile, are extended post-constitution and/or post-
`1‘”A For IV injection; 110
`dilution hold times in the drafi labeling supported by
`post constitution or
`microbiological data?
`dilution is described
`Is this NDA fileable? Ifnot, then describe why. "-—
`
`Additional Comments:
`
`Steven P. Donald, M.S.
`
`1/02/2012
`
`Reference ID: 3238837
`
`
`
`Reviewing Microbiologist
`
`
`
`
`Stephen Langille, Ph.D.
`Microbiology Secondary Reviewer
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Date
`
`1/02/2012
`
`Date
`
`
`
`
`
`Reference ID: 3238837
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`STEVEN P DONALD
`01/02/2013
`
`STEPHEN E LANGILLE
`01/02/2013
`
`Reference ID: 3238837
`
`
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