`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`204592Orig1s000
`
`MICROBIOLOGY / VIROLOGY REVIEW(S)
`
`
`
`
`
`
`
`
`
`
`
`
`Product Quality Microbiology Review
`
`4/04/2013
`
`
`
`NDA: 204592
`
`Drug Product Name
`Proprietary: Zorvolex Capsules
`Non-proprietary: diclofenac acid
`
`
`Review Number: 1
`
`
`Dates of Submission(s) Covered by this Review
`Submit
`Received
`Review Request
`12/20/2012
`12/20/2013
`3/19/2013
`
`
`
`
`Assigned to Reviewer
`3/21/2013
`
`
`
`
`Submission History (for 2nd Reviews or higher)
`None
`
`Applicant/Sponsor
`Name: Iroko Pharmaceuticals, LLC
`Address: 150 Rouse Blvd., Philadelphia, PA 19112
`Representative: Michelle Wilson, 100 Springhouse Dr. Suite 205,
`Collegeville, PA 19426
`Telephone: 513 829-1108
`
`
`Name of Reviewer: Steven P. Donald, M.S.
`
`Conclusion: Recommended for Approval
`
`
`
`Reference ID: 3288874
`
`
`
`3.
`
`
`4.
`
`
`A.
`
`B.
`
`NDA 204592
`
`
`
`
`
`
`Microbiology Review #1
`
`
`Product Quality Microbiology Data Sheet
`1.
`TYPE OF SUBMISSION: Original NDA
`
`2.
`
`SUBMISSION PROVIDES FOR: Manufacture and marketing of an oral
`drug product
`
`MANUFACTURING SITE:
`
`
`
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY: Capsules, Oral, 18 mg and 35 mg
`
`METHOD(S) OF STERILIZATION: N/A
`
`PHARMACOLOGICAL CATEGORY: Analgesic
`
`
`5.
`
`6.
`
`SUPPORTING/RELATED DOCUMENTS: None
`
`REMARKS: The sponsor is requesting the elimination of bioburden and
`specified microorganism testing for product release and approval of the stability
`protocol.
`
`C.
`
`
`
`
`filename: N204592r1.doc
`
`
`
`
`
`Reference ID: 3288874
`
`
`
`Page 2 of 8
`
`
`
`(b) (4)
`
`
`
`NDA 204592
`
`Microbiology Review #1
`
`Executive Summary
`
`I.
`
`Recommendations
`
`A.
`
`Recommendation on Approvability - Recommended for
`Approval
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable — N/A
`
`11.
`
`Summary of Microbiology Assessments
`
`A.
`
`B.
`
`C.
`
`D.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology - The drug product is
`manufactured using
`
`00(4)
`
`Brief Description of Microbiology Deficiencies —
`No product quality microbiology deficiencies were identified
`based upon the information provided.
`
`Assessment of Risk Due to NIicrobiology Deficiencies — N/A
`
`Contains Potential Precedent Decision(s)— [:1 Yes IX] No
`
`III.
`
`Administrative
`
`A.
`
`Reviewer's Signature
`
`B.
`
`Endorsement Block
`
`C.
`
`CC Block
`
`N/A
`
`Steven P. Donald, M.S.
`Microbiology Reviewer
`
`Stephen Langille, Ph.D.
`Senior Microbiology Reviewer
`
`5 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
`
`Reference ID: 3288874
`
`Page 3 of 8
`
`
`
`---------------------------------------------------------------------------------------------------------
`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
`04/05/2013
`
`STEPHEN E LANGILLE
`04/08/2013
`
`Reference ID: 3288874
`
`
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