`RESEARCH
`
`
`
`APPLICATION NUMBER:
`022501Orig1s000
`
`MICROBIOLOGY REVIEW(S)
`
`
`
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`
`
`
`
`
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`
`
`Product Quality Microbiology Review
`
`December 22, 2009
`
`
`
`
`
`
`22-501 Amendment
`
`
`
`
`NDA:
`
`Drug Product Name
`Proprietary:
`
`
`
`
`Non-proprietary: Norethindrone acetate & Ethinyl estradiol tablets
`
`
` Ethyinyl estradiol tablets &
`
`
`
`Ferrous fumarate tablets
`
`2
`
`
`
`
`Review Number:
`
`
`Dates of Submission(s) Covered by this Review
`Assigned to
`Submit
`Received
`Review Request
`Reviewer
`December 17, 2009 December 17, 2009 December 18, 2009 December 18, 2009
`
`
`
`Submission History (for amendments only)
`Submit Date(s)
`Microbiology Review #
`March 26, 2009
`1
`
`Review Date(s)
`November 20, 2009
`
`Warner Chilcott Company, Inc.
`100 Enterprise Drive, Roackaway, NJ 07866
`Alvin Howard, Sr. Vice President, RA
`973-442-3233
`
`Vinayak B. Pawar, Ph.D.
`
`The amended original NDA is recommended for
`approval from Product Quality Microbiology
`standpoint.
`
`
`
`Applicant/Sponsor
`Name:
`
`
`Address:
`
`Representative:
`Telephone:
`
`
`
`Name of Reviewer:
`
`Conclusion:
`
`
`
`
`
`
`
`(b) (4)
`
`
`
`NDA 22-501
`
`
`
`Product Quality Microbiology Data Sheet
`
`A.
`1.
`TYPE OF SUBMISSION: Amended original NDA
`
`2.
`
`Microbiology Review # 2
`
`
`SUBMISSION PROVIDES FOR: An agreement to add Microbial
`Limits test criteria to the drug product specification.
`
`
`
`MANUFACTURING SITE: Warner Chilcott Co. Inc., Fajardo, PR
`00738
`
`.
`
`3.
`
`
`4.
`
`B.
`
`C.
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY: Oral Tablets in 1mg NA, 10 mcg EE and 10
`mcg EE.
`
`METHOD(S) OF STERILIZATION: Non-sterile product.
`
`PHARMACOLOGICAL CATEGORY: Prevention of pregnancy.
`
`
`5.
`
`6.
`
`SUPPORTING/RELATED DOCUMENTS: None.
`
`REMARKS: The consult requests review of NDA 22-501 an oral drug product
` (Norethindrone acetate & Ethinyl estradiol tablets, Ethyinyl
`estradiol tablets & Ferrous fumarate tablets) for product quality microbiology
`review. The applicant proposed no microbial testing for the oral tablets. This
`resulted in a deficiency which was conveyed to Warner Chilcott and the sponsor
`was given the opportunity to discuss this deficiency in teleconference with the
`reviewer. In the teleconference held on December 14, 2009 Warner Chilcott
`agreed to amend the application to include the Microbial Limits test in their
`product specification.
`
`
`
`
`
`
`filename: C:\my documents\review\NDA\NO22501R2
`
`
`
`
`
`
`
`Page 2 of 6
`
`
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`(b) (4)
`
`
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`NDA 22-501
`
`Executive Summary
`
`
`
`
`
`Microbiology Review # 2
`
`
`Recommendations
`
`A.
`
`Recommendation on Approvability – The amended original
`NDA is recommended for approval.
`
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable – N/A
`
`
`Summary of Microbiology Assessments
`
`I.
`
`II.
`
`
`A. Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology – WC3016 1/l0 tablets are made
`
`
`
`
`
`
`Brief Description of Microbiology Deficiencies – None
`
`Assessment of Risk Due to Microbiology Deficiencies – N/A.
`
`
`B.
`
`C.
`
`III. Administrative
`
`
`A.
`
`
`
`B.
`
`
`C.
`
`Reviewer's Signature _____________________________
` Vinayak B. Pawar, Ph.D.
`
`
`
`Endorsement Block _____________________________
`
`
`
`Stephen E. Langille, Ph.D.
`
`CC Block
`N/A
`
`
`
`
`
`
`
`Page 3 of 6
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`
`
`(b) (4)
`
`3 Page(s) has ben Withheld in Full as b4 (CCI/TS) immediately
`following this page
`
`
`
`Application
`Type/Number
`--------------------
`NDA-22501
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`WARNER
`CHILCOTT CO INC
`
`------------------------------------------
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`VINAYAK B PAWAR
`12/23/2009
`
`STEPHEN E LANGILLE
`12/23/2009
`
`(b) (4)
`
`
`
`Product Quality Microbiology Review
`
`November 20, 2009
`
`
`
`
`
`
`22-501
`
`
`
`
`
`
`NDA:
`
`Drug Product Name
`Proprietary:
`
`
`
`
`Non-proprietary: Norethindrone acetate & Ethinyl estradiol tablets
`
`
` Ethyinyl estradiol tablets &
`
`
`
`Ferrous fumarate tablets
`
`
`
`
`Review Number:
`
`
`Dates of Submission(s) Covered by this Review
`Submit
`Received
`Review Request
`March 26, 2009 March 27, 2009
`September 16, 2009
`
`
`Submission History (for amendments only) – N/A
`
`
`Applicant/Sponsor
`Name:
`
`
`Address:
`
`Representative:
`Telephone:
`
`
`1
`
`Assigned to Reviewer
`September 17, 2009
`
`Warner Chilcott Company, Inc.
`100 Enterprise Drive, Roackaway, NJ 07866
`Alvin Howard, Sr. Vice President, RA
`973-442-3233
`
`Vinayak B. Pawar, Ph.D.
`
`The NDA is approvable upon resolution of the
`deficiency listed in the Product Quality
`Microbiology Assessment, Section 3.
`
`
`Name of Reviewer:
`
`Conclusion:
`
`
`
`
`
`(b) (4)
`
`
`
`NDA 22-501
`
`
`
`Product Quality Microbiology Data Sheet
`
`A.
`1.
`TYPE OF SUBMISSION:
`Original NDA
`
`2.
`
`Microbiology Review # 1
`
`
`SUBMISSION PROVIDES FOR: A new drug application.
`
`MANUFACTURING SITE: Warner Chilcott Co. Inc., Fajardo, PR
`00738
`
`3.
`
`
`4.
`
`B.
`
`C.
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY: Oral Tablets in 1mg NA, 10 mcg EE and 10
`mcg EE.
`
`METHOD(S) OF STERILIZATION: Non-sterile product.
`
`PHARMACOLOGICAL CATEGORY: Prevention of pregnancy.
`
`
`5.
`
`6.
`
`SUPPORTING/RELATED DOCUMENTS: None.
`
`REMARKS: The consult requests review of NDA 22-501 an oral drug product
` (Norethindrone acetate & Ethinyl estradiol tablets, Ethyinyl
`estradiol tablets & Ferrous fumarate tablets) for product quality microbiology
`review. The applicant proposes no microbial testing for the oral tablets.
`
`
`
`
`
`
`filename: C:\my documents\review\NDA\NO22501R1
`
`
`
`
`
`
`
`Page 2 of 9
`
`
`
`(b) (4)
`
`
`
`NDA 22-501
`
`Executive Summary
`
`
`
`
`
`Microbiology Review # 1
`
`
`Recommendations
`
`A.
`
`Recommendation on Approvability – This submission is
`approvable pending resolution of the deficiency listed in Product
`Quality Microbiology Assessment Section 3 of this review.
`
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable – N/A
`
`
`Summary of Microbiology Assessments
`
`I.
`
`II.
`
`
`A. Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology – WC3016 1/l0 tablets are made
`
`
`
`
`
`
`
`
`
`
`Brief Description of Microbiology Deficiencies – Microbial
`Limits test is not performed.
`
`Assessment of Risk Due to Microbiology Deficiencies – a
`medium risk due to inability to assess microbial contamination in
`the product.
`
`Reviewer's Signature _____________________________
` Vinayak B. Pawar, Ph.D.
`
`
`
`Endorsement Block _____________________________
`
`
`
`Stephen E. Langille, Ph.D.
`
`CC Block
`N/A
`
`
`B.
`
`
`C.
`
`A.
`
`
`
`B.
`
`
`C.
`
`
`III. Administrative
`
`
`
`
`
`
`
`
`Page 3 of 9
`
`
`
`6 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately
`following this page
`
`(b) (4)
`
`
`
`Application
`Type/Number
`--------------------
`NDA-22501
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`WARNER
`CHILCOTT CO INC
`
`------------------------------------------
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`VINAYAK B PAWAR
`11/24/2009
`
`STEPHEN E LANGILLE
`11/25/2009
`
`(b) (4)
`
`