CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICA TION NUMBER:
`
`2 1 -994
`
`MICROBIOLOGY REVIEW
`
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`2 1 -994
`
`MICROBIOLOGY REVIEW
`
`
`
`Product Quality Microbiology Review
`
`07 SEPT 2006
`
`NBA:
`
`V
`
`‘
`
`Drug Product Name
`Proprietary:
`Non-proprietary:
`
`-
`
`-
`
`21-994/N—000
`
`Travatan® Z (BAG-Free)
`travoprost ophthalmic solution 0.004%
`
`_
`
`Drug Product Priority Classification: S
`
`Review Number:
`
`1
`
`Dates of Submission(s) Covered b this Review
`
`18 NOV 2005
`
`21 NOV 2005
`
`30 NOV 2005
`
`Assi-ned to Reviewer
`29 NOV 2005
`
`Submission History (for amendments only) N/AV
`
`Applicant/Sponsor
`Name:
`'
`Address:
`
`Representative:
`
`Telephone:
`
`Name of Reviewer:
`
`Conclusion:
`
`'
`
`‘
`
`-
`
`Alcon, Inc.
`P.O.Box 62
`
`BOsch 69
`
`CH—6331 Hunenberg
`Switzerland
`Angela C. Kothe
`Assoc. Din, Reg. Affairs
`817-551-4933
`
`'
`
`Robert J. Mello, PhD.
`
`The application is recommended
`for approval from microbiology
`product quality standpoint.
`
`
`
`NDA 21-994/N4000
`
`Microbiology Review #1
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`TYPE OF SUBMISSION: Original NDA
`
`SUBMISSION PROVIDES FOR: Request to market a new drug
`
`MANUFACTURING SITE: Alcon Manufacturing, Ltd., ASPEX (Alcon
`Sterile Products Expansion) Manufacturing Facility, 6201 South Freeway,
`Fort Worth, TX
`'
`
`DOSAGE FORM,-ROUTE 0F ADMINISTRATION AND
`STRENGTH/POTENCY: Sterile, Preserved, Topical Ophthalmic
`Solution, 0.004% travoprost, packaged as 2.5ml/4ml and 5.0 ml/7.5 ml
`DROP-TAINER® plastic bottles.
`'
`'
`
`METHOD(S) OF STERILIZATION:
`0
`‘ »mxw - Packaging components
`(bottles/plugs/closures)
`'
`
`. _MWW. . mmmw - —Drug Product
`
`6.
`
`PHARMACOLOGICAL CATEGORY: OphthalmiCHProstaglandins
`
`SUPPORTING/RELATED DOCUMENTS:
`o Microbiology review dated 09 JUNE 2005 (V. Pawar) for NDA 21-
`862, Nevenac 0.1% Suspension.
`v
`I
`o Microbiology review dated 07 AUG 2000 (V, Pawar) for NDA 21-
`25 7/N-000, Travatan®, Ophthalmic Solution
`0 Microbiology review dated 09 NOV 2005 (J. Metcalfe) for NDA 21—
`257/SCP-016, Travatan® Ophthalmic Solution.
`
`a?
`
`REMARKS: The'consult requests review of NDA 21-994. Six volumes of
`module 2 and five volumes of module 3 were submitted for review. An
`amendment to this NDA (21-994/N~000 BC, letter date 10 Jan 2006) was
`submitted in response to a request for additional information On a referenced
`testing standard. It is reviewed here as part of the original submission.
`A phone and e-mail request was sent 09 AUG 2006 to A. Kothe, Alcon Labs, for
`additional information on the status of the sterile filter validation of microbial
`retention. The report was provided for my review electronically, Via e-mail, on 10
`AUG 2006 and was submitted as an amendment to the NDA (NDA 21-994/N000
`BC, Letter date 15 AUG 2006.).
`A subsequent amendment was submitted (NDA 21~994/N000 BC, Letter date 01
`
`SEPT 2006) to change the pHspeciflcation from
`as a result of
`
`particulate generation ./
`-
`-
`‘
`4'
`'
`,, ) observed MW,
`‘
`
`at
`~-
`
`Page 2 of 18
`
`
`
`Microbiology Review #1
`-
`NDA 21—994/N-000
`
`
`An e—mail request was sent 25 AUG 2006 to A. Kothe, Alcon Labs, for additional
`information on the media fill program. A response was received on 07 SEPT
`2006 and is incorporated into the body of this review.
`
`Filename: N021994N000R1.doc
`
`Appears This Won;
`On Original
`
`,
`
`Page 3 of 18
`
`
`
`NDA 21—994/N-000
`
`Microbiology Review #1
`
`M E
`
`xecutive Summary '
`
`I.
`
`Recommendations
`
`A.
`
`B.
`
`Recommendation on Approvability - The application is
`recommended for approval from microbiology product quality
`standpoint.
`
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable - N/A
`
`II.
`
`Summary of Microbiology Assessments
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology - The product Travatan®—Z (BAC-
`free) is a sterile, preserved ophthalmic topical solution that does
`not contain the BAC/EDTA (benzalkonium chloride/edetate
`disodium) preservative®system found1n a .similar drug product of
`the applicant ("l“,.®ravatan® Ophthalmic Solution 0004% NDA 21—
`257). Travatan®~Z (BAC-free) obtains its preservative
`
`effectiveness by the inclusion of a
`and
`~”N"
`system in the formulation. The drug productis
`
`into plastic DROP—TAINER® bottles. Packaging
`components are \—~ by‘ Wmmwmm at a contract
`ma.
`..tirmf WW.
`
`B.
`
`Brief Description of Microbiology Deficiencies — No deficiencies
`noted
`
`a.“
`
`C.
`
`Assessment of Risk Due to Microbiology Deficiencies — N/A
`
`III.
`
`Administrative
`
`. A.
`
`Reviewer's Signature
`Robert J. Mello, PhD:
`
`'B.
`
`Endorsement Block
`
`Stephen E. Langille, PhD.
`
`V C.
`
`CC Block
`In DFS -
`
`M—
`
`Page 4 of 18
`
`
`
`13
`
`Page(s) Withheld
`
`/ Trade Secret / Confidential
`
`Draft Labeling
`
`Deliberative Process
`
`Withheld Track Number: Microbiology— l
`
`
`
`u--------—---------------------------—------uuqnu------------------_-_--_-_----_----___-----------------—---u-------
`
`This is a representation of an electronic record that was signedpelectronically and
`---------------------—--—~--—------------------_-__-------------_---_----------------_---------——--——-——-__-_-______
`this page is the manifestation of the electronic signature.
`
`Robert Mello
`
`9/8/2006 03:27:53 PM
`MICROBIOLOGIST
`
`Recommend for approval
`
`Stephen Langille
`9/8/2006 03:36:46 PM
`MICROBIOLOGIST
`
`
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