CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPROVAL PACKAGE FOR:
`
`APPLICATION NUMBER
`
`21-344
`
`Microbiology Review(s)
`
`
`
`APPROVAL PACKAGE FOR:
`
`APPLICATION NUMBER
`
`21-344
`
`Microbiology Review(s)
`
`
`
`Product Quality Microbiology Review
`Review for HFD-150
`
`29 JAN 2002
`
`NDA: 21-344/N/BI
`
`Name of Drug: Faslodex (Fulvestrant) 250/5ML Injection
`
`Review Number: 2
`
`Submission Date: 10—DEC—2001
`
`Applicant: AstraZeneca Pharmaceuticals
`
`Name of Reviewer: David Hussong, PhD.
`
`Review Recommendation: Approve (see page 4)
`
`
`
`NDA 21-344
`Microbiology Review #2
`
`
`Product Quality Microbiology Data Sheet
`
`NDA: 21—344
`
`REVIEW NUMBER: 2
`
`REVIEW DATE:
`
`29-JAN-2002
`
`TYPE OF SUPPLEMENT: N/A
`
`SUPPLEMENT PROVIDES FOR: N/A
`
`APPLICANT/SPONSOR:
`
`AstraZeneca Pharmaceuticals
`Name:
`Representative: E. Jane Valas, PhD.
`Telephone:
`(302) 886-2122
`
`MANUFACTURING SITE:
`iPR Pharmaceuticals
`
`Carolina, Puerto Rico
`
`DRUG PRODUCT NAME:
`
`FaslodexTM Injection
`Proprietary:
`fulvestrant
`Non-proprietary:
`Drug Priority Classification: Standard
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`
`STRENGTH/POTENCY: 250 mg/5 ML
`
`METHOD(S) OF STERILIZATION:
`
`~——--
`
`PHARMACOLOGICAL CATEGORY: Anti-estrogen receptor agent
`that inhibits the growth of estrogen sensitive breast cancer cells.
`
`DOCUMENT/LETTER DATE: 28-MAR-2001 (initial submission)
`RECEIPT DATE: 28-MAR-200]
`CONSULT DATE: N/A
`
`DATE OF AMENDMENTS: 10-DEC-2001 (subject of this review)
`ASSIGNED FOR REVIEW:
`l3-DEC-2001
`SUPPORTING/RELATED DOCUMENTS: N/A
`
`10.
`
`11.
`
`99993.“?
`
`C.
`
`REMARKS: The original submission was reviewed in Microbiologist’s
`Review #1 (06-NOV-2001), which produced six comments that were provided
`(by FAX dated 19-Nov-2001) to the applicant from that review. The applicant
`
`
`
`Page 2 of9
`
`
`
`Microbiology Review #2
`NDA 21-344
`
`
`replied to these cements in their amendment dated lO-DEC-200] , which is the
`subject of this review.
`
`APPEARS m IS w
`0N ORIGINAL M
`
`APPEARS rms WA
`on ORIGINAL Y
`
`Page 3 of9
`
`
`
`Microbiology Review #2
`NDA 21—344
`
`
`Executive Summafl
`
`1.
`
`Recommendations
`
`A.
`
`B.
`
`Recommendation on Approvability - APPROVE
`
`Recommendation on Phase 4 Commitments and/or
`
`Agreements, if Approvable - n/a
`
`11.
`
`Summary of Microbiology Assessments
`
`A.
`
`B.
`
`C.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology - The product is manufactured in
`two strengths by preparing 2 fill volumes in M
`syringes. The solution is non—aqueous and is filtered through
`4"," membranes, then processed by A
`-
`
`Brief Description of Microbiology Deficiencies — n/a
`
`Assessment of Risk Due to Microbiology Deficiencies — n/a
`
`11].
`
`Administrative
`
`(<3
`
`A.
`
`B.
`
`C.
`
`Reviewer’s Signature
`
`Endorsement Block
`
`David Hussong/29—JAN-2002
`Peter Cooney/Date
`
`CC Block
`cc
`
`Original NDA 21-344
`HFD-lSO/Division File/NDA 21-344
`
`HFD-l SO/CSO/Amy Baird
`
`D.
`
`File Name:
`d:\NDA\21-344rv2.doc
`
`Page 4 of9
`
`
`
`Microbiology Review #2
`NDA 21-344
`
`
`Product uali Microbiolo Assessment
`
`Deficiencies and Comments from Microbiology Review #1 were conveyed to the
`applicant in a FAX dated November 19, 2001. Comments are copied into this review and
`followed by a review of the applicant’s reply.
`
`Comment #1. Process flow descriptions did not indicate which fill line was used and
`could not be linked to specific rooms or processing areas. Please identify the building and
`rooms where . —"
`is done. The t — line should be described
`so it can be associated with the lines that are validated in the process simulations (media
`fill
`‘—'
`‘
`
`is
`—— _ of FASLODEXV
`Review ofResponse #1: The ,
`at Vetter
`_
`performed in the filling suite, ——
`Ravensburg Germany. The only
`Pharma-Fertigung GmbH
`all——
`syringe filling and
`filling line 1
`"'
`the floor plan).
`Y machine (
`-
`facility (Appendix
`-—
`4"- is shown on the site plan for the
`1(a) on page 25). A floor plan for the production area was provided in Appendix 1(b), on
`pages 4 and 5. » m of FASLODEX) and the support rooms
`on!—
`, were outlined on the
`floor plan to show the processing areas for this product. A copy of the manufacturing
`process flow diagram (page 6) identifies the rooms where v manufacturing
`a ' are carried out.
`
`The process flow describes preparation of the bulk solution .
`
`-
`
`The bulk is .
`
`-—————
`
`Filtration is done by a _.a filter and the filtrate is received in
`The sterile bulk is then
`~—~_
`'F'"
`(sterilizing) is done at the point of syringe filling §
`_—
`. The filled syringe barrels are closed with plunger stoppers
`
`where
`
`and seals.
`
`ACCEPTABLE
`
`Comment #2. Please summarize methods and acceptance criteria for environmental
`microbiology tests conducted in the sterile facility. Emphasis should be placed on the
`critical _ G}-
`, areai Fill and support rooms should be identified.
`
`Review ofResponse #2. Environmental microbiology monitoring of the FASLODEX
`manufacture areas was described in SOPs provided in Appendix 9. These SOPs are listed
`below.
`
`Page 5 of9
`
`
`
`Redacted
`
`*f
`
`peges of trade
`
`secret and/or
`
`
`
`This is‘a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`David Hussong
`2/14/02 09:35:01 AM
`MICROBIOLOGIST
`
`Peter Cooney
`2/14/02 10:37:33 AM
`MICROBIOLOGIST
`
`
`
`REVIEW FOR HFD—ISO
`
`MICROBIOLOGY STAFF
`
`MICROBIOLOGIST’S REVIEW #1 OF NDA
`
`November 6, 2001
`
`l.
`
`NDA
`
`21-344
`
`APPLICANT
`
`AstraZeneca Pharmaceuticals
`
`1800 Concord Pike
`
`PO. Box 8355
`
`Wilmington, DE 19803-8355
`
`AGENTS FOR
`
`iPR Pharmaceuticals
`
`Carolina, Puerto Rico
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`].
`
`2.
`
`3.
`
`PRODUCT NAMES: FaslodexTM (fulvestrant) Injection
`
`DOSAGE FORM AND ROUTE OF ADMINISTRATION: There are two
`
`. presentations: both are prefilled syringes of 50 mg/mL. One is a single 5 mL
`syringe containing 5 mL of drug solution. The other is a single package of 2
`syringes (5 cc capacity) containing 2.5 mL of drug solution. Both are for
`intramuscular injection.
`
`METHODS S! OF STERILIZATION: Q
`
`PHARMACOLOGICAL CATEGORY: Anti—estrogen receptor agent that inhibits
`the growth of estrogen sensitive breast cancer cells.
`
`DRUG PRIORITY CLASSIFICATION: Standard
`
`DATE OF INITIAL SUBMISSION: March 28, 2001
`
`DATE OF AMENDMENT: none
`
`RELATED DOCUMENTS: none
`
`4.
`
`ASSIGNED FOR REVIEW: May 22, 2001
`
`REMARKS: The applicant has submitted this NDA on behalf of iPR Pharmaceuticals in
`Puerto Rico. The NDA was submitted with a request for expedited review, but the
`administrative management system reports it has a standard review (S) classification.
`The submission was provided as two introductory jackets with summary
`information. Technical information was electronically transmitted and reviewed.
`
`
`
`
`
`NDA 21-344 Microbiologist‘s Review #1
`
`CONCLUSIONS: The application is approvable pending resolution of microbiology
`issues. Specific deficiencies are provided in “List of Microbiology Deficiencies and
`Comments,” at the end of this review.
`
`\ U
`
`)\
`
`David Hussong, PhD.
`
`D.
`
`cc:
`
`HFD l60/Consult File
`HFD ISO/Division File
`
`HFD 150 /CSO/Amy Baird
`HFD 805/D. Hussong
`
`Drafted by: D. Hussong, 1 1/06/2001
`R/D initialed by: P. Cooney
`
`Filename, d:\nda\2 l -344rvl .DOC
`
`
`
`Page 2
`
`
`
`Redacted
`
`,Z.
`
`peges of trade
`
`”secret and/or
`
`‘confidential
`
`
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`David Hussong
`11/6/01 02:49:30 PM
`MICROBIOLOGIST
`
`Peter Cooney
`11/6/01 02:58:54 PM
`MICROBIOLOGIST
`
`
`
`3
`
`41.1 W
`
`5“~ Pa?“ 90'
`
`67°: % MoR quid 3/92/03;
`
`lBPEARS nus my
`0N ORIGINAL
`
`
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