`
`CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`21-023
`
`MICROBIOLOGY REVIEwgS)
`
`
`
`
`
`REVIEW FOR HFD-SSO
`
`FEB 2 3 3009
`
`OFFICE OF NEW DRUG CHEMISTRY
`
`MICROBIOLOGY STAFF
`
`MICROBIOLOGIST‘S REVIEW #4 OF NDA
`
`February 2, 2000
`
`A.
`
`1. NBA
`
`21-023
`
`SPONSOR
`
`Allergan, Inc.
`
`2525 Dupont Circle
`P.O. Box 19534
`
`Irvine, CA 92623—9534
`
`
`
`2.
`
`PRODUCT NAMES: Cyclosporine
`
`3. DOSAGE FORMAND ROUTE OF ADMINISTRATION: m Vial,
`Ophthalmic Emulsion
`
`4. METHOD! S! OF STERILIZATION:
`
`.-——..
`
`5.
`
`PHARMACOLOGICAL CATEGORY: Immunornodulator/Anti—Inflammatory Agent
`
`6. DRUG PRIORITY CLASSIFICATION:
`
`Br.
`
`1. DATE OF INITIAL SUBMISSION: February 24, 1999
`
`2. DATE OF AMENDMENT: December 8, 1999
`
`3.
`
`RELATED DOCUMENTS: Microbiology reviews # 1, 2, and 3 of NDA 21-023
`
`4. ASSIGNED FOR REVIEW: December20, 1999
`
`~ C. REMARKS: This is a response to an “approvable letter” to the sponsor.
`
`
`
`
`
`
`
`NDA 21—023 (Cyclosporine Ophthalmic Emulsion)
`Microbiologist's Review # 4
`
`
`D_ CONCLUSIONS; This application is rF-r‘nmmendcd for approval on the basis of product
`quality microbiology.
`
`ad
`
`E13311 Riley, PhD.
`
`cc:
`
`Original NDA 21-023
`HFD SSO/Consull File
`
`HFD SSO/L Gorski
`
`HFD 550/1" so
`
`HFD SOS/Consult File
`
`HFD'ESOSIB. Riley
`
`Drafted by: B. Riley, 2/2/00
`RID initialed by: P. Cooneyy,
`
`nil/:D/wod
`
`Page 2
`
`
`
`Q _ Page(s) Withheld
`
`
`
`
`
`
`
`
`
`
`
`REVIEW FOR HFD-SSO
`OFFICE OF NEW DRUG CHEMISTRY
`MICROBIOLOGY STAFF
`
`JQ
`
`36> ,
`53%?
`
`MICROBIOLOGIST'S REVIEW # 3 OF NDA
`
`July 28, 1999
`
`l.
`
`NDA
`
`21—023, Original Amendment BI
`
`SPONSOR
`
`Allergan Inc.
`
`2525 Dupont Drive
`PO. Box 19534
`
`Irvine, CA 93623-9534
`
`PRODUCT NAMES: RESTASISTM (CycIOSporine Ophthalmic Emulsion, 0.05%)
`
`DOSAGE FORMiAND ROUTE OF ADMINISTRATION: W vial,
`Ophthalmic Emulsion
`
`METHODS! OF STERILIZATION:
`
`
`
`PHARMACOLOGICAL CATEGORY: Immunomodulator/Anti-Inflammatory Agent
`
`DRUG PRIORITY CLASSIFICATION:
`
`DATE OF INITIAL SUBMISSION: February 24, 1999.
`
`DATE OF AMENDIVIENT: July 13, 1999
`
`3.
`
`4.
`
`RELATED DOCUMENTS:
`
`ASSIGNED FOR REVIEW: July 21, 1999
`
`REMARKS: This review considers an amendment submitted by the sponsor to address
`microbiology deficiencies.
`
`
`
`NDA 21—023 (Cyclosporine Ophthalmic Emulsion)
`
`Microbiologisl's Review # 3
`
`D. CONCLUSIONS: This submission is approvable, pending resolution of Microbiological
`deficiencies. Please see “Microbiologist's List of Deficiencies” at the end of this review.
`
`qumumwpuo.
`
`5/
`
`f
`
`{5 i
`
`CC:
`
`HFD 550/Consult File
`
`HFD SSO/Tso
`
`HFD 550fBoyd
`HFD SSO/Gorski
`
`LHHDSSOHqg
`HFD SOS/Consult File
`
`HFD SOS/B. Riley
`
`Drafted by: B. Riley, 7/28/99
`RID initialed by: P. Cooney,
`
`
`
`Page 2
`
`
`
`
`
`5 ' Page(s) Withheld
`
`
`
`REVIEW FOR HFD—SSO
`OFFICE OF NEW DRUG CHEMISTRY
`MICROBIOLOGY STAFF
`MICROBIOLOGIST’S REVIEW # 2 OF NDA
`
`“Q
`
`(3:9/
`“932
`
`July 28, 1999
`
`A.
`
`1.
`
`NDA
`
`21-023, Original Amendment BC
`
`SPONSOR
`
`Aliergan Inc.
`2525 Dupont Drive
`PO. Box 19534
`
`Irvine, CA 93623-9534
`
`2.
`
`PRODUCT NAMES: RESTASISTM (Cyclosporine Ophthalmic Emulsion, 0.05%)
`
`3. DOSAGE FORM AND ROUTE OF ADMINISTRATION
`Ophthalmic Emulsion
`'
`
`4. METHODISI OF STERILIZATION:
`
`
`
`
`
`vial,
`
`5.
`
`PHARMACOLOGICAL CATEGORY: ImmunomodulatoriAnti-Inflammatory Agent
`
`6. DRUG PRIORITY CLASSIFICATION:
`
`1.
`
`DATE OF INITIAL SUBMISSION: February 24, 1999
`
`2. DATE OF AMENDMENT: July 12, 1999
`
`3.
`
`RELATED DOCUMENTS:
`
`4. ASSIGNED FOR REVIEW: July 21, 1999
`
`REMARKS: This review considers an amendment submitted by the sponsor to address
`chemistry deficiencies.
`
`
`
`
`
`
`
`NDA 21—023 (Cyciosporine Ophthalmic Emulsion)
`
`Mierobiologist's Review # 2
`
`D. CONCLUSIONS: This submission is not annrovable. Please see “Microbiologist’s List of
`Deficiencies".
`
`Bryan Riley, PhD.
`
`[If
`
`m
`
`CC:
`
`HFD 550/Consult File
`
`HFD SSOFTSO
`
`HFD SSOfBoyd
`HFD SSO/Gorski
`
`HFD SSOng
`HFD 805lC0nsull File
`
`HFD 805/8. Riley
`
`Drafted by: B. Riley, 7/28/99"
`
`RID initialed by: P. Cooney,
`
`
`
`
`
`Page 2
`
`
`
`
`
`9 . Page(s) Withheld
`
`
`
`
`
`
`
`REVEEW FOR HFD-SSO
`
`OFFICE OF NEW DRUG CHEMISTRY
`
`MICROBIOLOGY STAFF
`
`MICROBIOLOGIST'S REVIEW # 1 OF NDA
`
`May 14, 1999
`
`1. NDA
`
`21—023
`
`SPONSOR
`
`Allergan Inc.
`2525 Dupont Drive
`PO. Box 19534
`
`Irvine, CA 93623-9534
`
`2.
`
`PRODUCT NAMES: RESTASISTM (Cyclosporiue Ophthalmic Emulsion, 0.05%)
`
`3. DOSAGE FORM AND ROUTE OF ADMINISTRATION: Single-use vial,
`Ophthalmic Emulsion
`
`4. M'.ETHOD(S) OF STERILIZATION: Ere-“~—
`
`j
`
`'5.
`
`PHARMACOLOGICAL CATEGORY: ImmunomodulatorlAnti-Inflammatory Agent
`
`6. DRUG PRIORITY CLASSIFICATION:
`
`1. DATE OF INITIAL SUBMISSION: February 24, 1999
`
`2. DATE OF AMENDMENT:
`
`3.
`
`RELATED DOCUMENTS:
`
`4. ASSIGNED FOR REVIEW: March 15, 1999
`
`REMARKS: The drug productIS a stenle preservative-free «an. emulsion
`containing 0.05% Cyclosporine. The drug product15 packagedm a single-use vial”_(O.'4 mL
`fill volumem 0.9 1111.. capacity) ”-— manufactured as part of a M
`f’
`
`
`
`
`
`NDA 21—023
`
`Microbiologist's Review # 1
`
`D. CONCLUSIONS: This submission is approvable, pending resolution of microbiological
`issues. Please see “Microbiologist’s List of Deficiencies”.
`
`1L9
`[
`
`,
`
`-
`
`Bryan Riley, PhD.
`
`
`
`CC:
`
`HPD SSO/Consult File
`
`HFD 550/110
`
`HFD SSO/Boyd
`HFD SSO/Gorski
`
`HFD 550mm
`HFD SOS/Consult File
`
`HFD 8051B. Riley
`
`Drafted by: B. Riley, 5/14/99
`R/D initialed by: P. Cooney,
`
`
`
`(a ' Page(s) Withheld
`
`
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