CENTER FOR DRUG EVALUATION AND RESEARCH ’
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`APPLICA TI0N NUMBER:
`
`50—790 / S-002
`
`ADMINISTRATIVE DOCUMENTS
`
`‘
`
`AND '
`
`CORRESPONDENCE
`
`

`

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`Pub'ic”93"“ Service
`
`NDA 50-790/S—002
`
`CBE-30 SUPPLEMENT
`
`Food and Drug Administration
`Rockville, MD 20857
`
`_
`Allergan, Inc.
`Attention: Elizabeth Bancroft
`
`Senior Director, Regulatory Affairs
`2525 Dupont Drive
`PO. Box 19534
`
`Irvine, California 92623-9534
`
`Dear Ms. Bancroft:
`
`We have received your supplemental drug application submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act for the following:
`
`Name the Product:
`
`Restasis (cyclosporine ophthalmic emulsion) Ophthalmic Emulsion,
`0.05%
`
`NDA Number:
`
`50-790
`
`Supplement number:
`
`S-002
`
`Date of supplement:
`
`June 27, 2003
`
`Date of receipt:
`
`June 30, 2003
`
`.3..-
`This supplemental application, submitted as “Supplement - Changes Being Effected” proposes
`
` - v
`the addition of
`
`Unless we notify you within 60 days of the receipt date that the application is not sufficiently
`complete to permit a substantive review, we will file the application on August 28, 2003, in
`accordance with 21 CFR 3 14. 1 0 l (a).
`
`I
`
`All communications concerning this supplement should be addressed as follows:
`
`US. Postal Service:
`Food and Drug Administration
`Center for Drug Evaluationvand Research
`Division of Anti-Inflammatory, Analgesic
`and Ophthalmic Drug Products, HFD-S50
`5600 Fishers Lane
`Rockville, Maryland 20857
`
`Courier/Ovemight Mail:
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Anti-Inflammatory, Analgesic
`and Ophthalmic Drug Products, HFD-550
`9201 Corporate Boulevard
`. Rockville, Maryland 20850-3202
`
`

`

`NDA 50—790/S—002
`
`Page 2
`
`If you have any questions, call Lori M. Gorski, Project Manager, at (301) 827-2090.
`
`Sincerely,
`
`{See appended electronic Signature page}
`
`_.
`
`Carmen DeBellas, R.Ph.
`Chief, Project Management Staff
`Division of Anti—Inflammatory, Analgesic,
`and Ophthalmic Drug Products, HFD-5 50
`Office of Drug Evaluation V
`Center for Drug Evaluation and Research
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Lori Gorski
`
`7/2/03 02:38:09 PM
`Lori Gorski has signed for Carmen DeBellas
`
`

`

`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`PUBLIC HEALTH SERVICE
`REQUEST FOR CONSULTATION
`FOOD AND DRUG ADMINISTRATION
`
`
`TO (Division/Office):
`
`Peter Cooney
`Pkln 188-08
`
`
`DHHSIFDAICDERIOPSIONDCIHFD-805
`DHHS/FDA/CDER/OND/DAAODP HFD-550
`
`
`DATE
`DATE OF DOCUMENT
`TYPE OF DOCUMENT
`
`NDA No.
`
`
`
`July 1, 2003
`50—790/S-002
`June 27, 2003
`
`
`
`Chemistry supplement
`
`NAME OF DRUG
`DESIRED COMPLETION DATE
`PRIORITY CONSIDERATION
`CLASSIFICATION OF DRUG
`
`
`
`
`
`
`FROM:
`
`Lori Gorski
`
`phone 7-2521
`
`October 1 , 2003
`Anti-infective
`Restasis (CVCIOSPOH'ne Ophthalmic
`
`emulsion)
`
`NAME OF FIRM:
`
`Allergan
`
`REASON FOR REQUEST
`
`I. GENERAL
`
`‘
`
`ll. BIOMETRICS
`
`STATISTICAL EVALUATION BRANCH
`
`STATISTICAL APPLICATION BRANCH
`
`El DISSOLUTION
`D BIOAVAILABILTY STUDIES
`El PHASE IV STUDIES
`
`El CHEMISTRY REVIEW
`EI PHARMACOLOGY
`El BIOPHARMACEUTICS
`CI OTHER (SPECIFY BELOW):
`
`III DEFICIENCY LETTER RESPONSE
`El PROTOCOL-BIOPHARMACEUTICS
`El
`IN-VIVO WAIVER REQUEST
`
`El CLINICAL
`
`'
`
`COMMENTSISPECIAL INSTRUCTIONS:
`
`V. SCIENTIFIC INVESTIGATIONS
`
`El PRECLINICAL
`
`Allergan has requested a CBE-30 supplement for the change in -
`
`
`
`.i Restasis.
`
`If you have any questions, please contact Lori Gorski, Project Manager at 7-2521.
`
`Please cc GORSKIL and NGL on the DFS email when this review has been completed. Thanks
`
`SIGNATURE OF REQUESTER
`
`SIGNATURE OF RECEIVER
`
`METHOD OF DELIVERY (Check one)
`XX Through Document Room
`
`HAND
`
`SIGNATURE OF DELIVERER
`
`
`
`
`
`
`
`
`
`
`
`
`El NEW PROTOCOL
`El PROGRESS REPORT
`III NEW CORRESPONDENCE
`El DRUG ADVERTISING
`El ADVERSE REACTION REPORT
`El MANUFACTURING CHANGE/ADDITION
`El MEETING PLANNED BY
`
`El PRE—NDA MEETING
`El END OF PHASE 2
`El RESUBMISSION
`El SAFETY/EFFICACY
`El PAPER NDA
`III CONTROL SUPPLEMENT
`
`_
`
`-
`
`‘
`
`_
`
`El RESPONSE TO DEFICIENCY LETTER
`El FINAL PRINTED LABELING
`'
`El LABELING REVISION
`El ORIGINAL NEW CORRESPONDENCE
`El FORMULATIVE REVIEW
`El
`'OTHER (SPECIFY BELOW):
`.
`- XX ChemIstry supplement
`
`7
`
`
`
`
`
`
`
`
`
`
`EI TYPE A OR B NDA REVIEW
`EI END OF PHASE II MEETING
`
`EI CONTROLLED STUDIES
`
`El PROTOCOL REVIEW
`
`
`Ill. BIOPHARMACEUTICS
`
`
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature. '
`
`Lori Gorski
`
`7/1/03 11:07:41 AM
`consult sent 7/1/03
`
`