`
`APPLICA TI0N NUMBER:
`
`50-790 ‘/ 5-002
`
`MICROBIOLOGY REVIEW
`
`
`
`Product Quality Microbiology Review
`
`Consult Review for HFD-SSO
`
`19 August 2003 '
`
`NDA:
`
`50-790/SCS-002
`
`Drug Product Name:
`
`Proprietary: RESTASISTM
`Non-proprietary: cyclosporine ophthalmic emulsion
`Drug Product Classification: ophthalmic
`
`Review Number:
`
`1
`
`Subject of this Review:
`Submission Date: 27 June 2003
`
`30 June 2003
`' Receipt Date:
`01 July 2003
`Consult Date:
`Date Assigned for Review:
`30 July 2003
`
`Applicant/sponsor:
`Name:
`Allergan
`Address:
`2525 DuPont Drive, PO. box 19534, Irvine, CA 92623-9534
`Representative: Elizabeth Bancroft
`Telephone:
`(714) 246—4391
`
`Name of Reviewer: Paul Stinavage
`
`Conclusion:
`
`The application is recommended for approval on the basis of
`product quality microbiology.
`
`
`
`‘ Microbiology Review #1
`NDA 50-790/SCS—002
`
`
`Product Quality MicrobiOlogy Data Sheet.
`
`TYPE OF SUPPLENIENT: Changes Being Effected in 30 Days
`
`SUPPLEMENT PROVIDES FOR: Two additional L~ ~- -————7
`C,,- *J
`
`#
`
`" u
`
`1
`
`MANUFACTURING SITE:
`
`
`
`DOSAGE FORM, ROUTE 0F ADMINISTRATION AND
`STRENGTH/POTENCY: 0.05% in unit dose form-fill-seal containers.
`
`‘METHOD(S) OF STERILIZATION: ,
`
`,
`
`PHARMACOLOGIC CATEGORY: lacrimator
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`A.
`
`B.
`
`C.
`
`SUPPORTING/RELATED DOCUMENTS: (none)
`
`REMARKS:
`
`'
`
`This submission originally was NDA 21-023 and was reviewed by
`Dr. Bryan Riley of the Microbiology Team.
`
`Filename: N50790$2.doc
`
`——————-————_————_—
`
`Page 2 of 5
`
`
`
`NDA 50—790/SCS-002
`
`Microbiology Review #1
`
`M E
`
`xecutive Summafl
`
`I.
`
`Recommendations
`
`A.
`
`B.
`
`Recommendation on Approvability— The application15
`recommended for approval on the basis of product quality
`microbiology.
`
`Recommendation on Phase 4 Commitments and/or
`Agreements, if Approvable
`Not applicable
`
`H.
`
`Summary of Microbiology Assessments
`
`A.
`
`BriefDescription of the Manufacturing Processes that relate to
`Product Quality Microbiology
`:‘m
`
`B.
`
`Brief Description of Microbiology Deficiencies — None
`
`HI.
`
`Administrative
`
`A.
`
`B.
`
`C.
`
`Reviewer’s Signature
`
`Endorsement Block
`Paul Stinavage/l9 August 2003
`PH. Cooney/
`
`,
`
`CC Block
`cc:
`
`Original NDA 50-790
`HFD-550/Division File/NDA 50-790/L. Ng/L. Gorski
`
`Page 3 of 5
`
`
`
`WITHHOLD l
`
`PAGE(S)
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`-
`
`Paul Stinavage
`8/25/03 05:34:18 AM
`MICROBIOLOGIST
`'Two additional
`
`~—————————————————————
`
`Peter Cooney
`8/27/03 01:29:09 PM
`MICROBIOLOGIST '
`
`
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