`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`21-450
`
`MICROBIOLOGY REVIEW
`
`
`
`Product Quality Microbiology Review
`Review for HFD—120
`
`06 JUNE 2002
`
`NBA: 21-450
`
`Drug Product Name
`Proprietary: Zomig® Nasal Spray
`Non-proprietary: Zolmitriptan
`Drug Product Classification: Standard
`
`Review Number: 1
`
`Subject of this Review
`Submission Date: 27-Feb-02
`
`Receipt Date: 27~Feb-02
`Consult Date: l3-March-02
`
`Date Assigned for Review: i8-March-02
`
`Submission History (for amendments only)
`Date(s) of Previous Submission(s): None
`Date(s) of Previous Micro RevieW(s): None
`
`Applicant/Sponsor
`Name: iPR Pharmaceuticals, Inc.
`
`Address: PO. Box 1967, Carolina, PR 00984-1967
`Representative: not provided
`Telephone: 800-456-3669
`
`US. Agent
`Name: AstraZeneca Pharmaceuticals, LP
`
`Address: 1800 Concord Pike, P.0. Box 8355, Wilmington, DE 19803-8355
`Representative: Kevin McKenna
`Telephone: 302-886-2742
`
`Name of Reviewer:
`
`Neal Sweeney, PhD.
`
`Conclusion: Recommend Approval
`
`
`
`
`
`NDA 21-450
`Microbiology Review #1
`
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`l.
`
`2.
`
`TYPE OF SUPPLEMENT: Nz’A
`
`SUPPLEMENT PROVIDES FOR: N/A
`
`MANUFACTURING SITE: AstraZeneca
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY: Single dose, non-preserved, zolmitriptan (5
`mg,
`--‘f"‘_‘_‘— U, nasal spray for intranasal administration.
`
`METHOD(S) OF STERILIZATION : Non-sterile product
`
`PHARMACOLOGICAL CATEGORY: Selective inhibitor of 5-HT”)
`and 5-HT“; receptors. Indicated for the acute treatment of migraine with
`or without aura in adults.
`
`B.
`
`SUPPORTINGIRELATED DOCUMENTS: None
`
`
`
`
`The drug product is not labeled as a
`
`sterile product.
`
`filename: 21-450, Zornig (zolmitriptan) nasal spray, iPR Pharmaceuticalsdoc
`
`APPEESS THiS WAY
`
`{iii ORiGiitAL
`
`
`
`Page2of10
`
`
`
`
`
`Microbiology Review #1
`NDA 21-450
`
`
`Executive Summagy
`
`1.
`
`Recommendations
`
`A.
`
`is
`on Approvability — NDA 21-450
`Recommendation
`recommended for approval from the standpoint of product quality
`microbiology.
`See “Product Quality Microbiology Assessment”
`section of this review.
`
`B.
`
`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 -
`
`EWJ
`
`
`
`The drug product is not labeled as a sterile
`
`product.
`
`B.
`
`Brief Description of Microbiology Deficiencies ~— No product
`quality microbiology deficiencies were
`identified
`for
`this
`submission.
`
`C.
`
`Assessment of Risk Due to Microbiology Deficiencies - N/A
`
`III.
`
`Administrative
`
`A.
`
`B.
`
`C.
`
`Reviewer's Signature
`
`Endorsement Block
`
`Microbiologist: Neal Sweeney
`Microbiology SupervisorfTeam Leader: Peter Cooney
`
`CC Block
`cc:
`
`Original NDA 21-450
`HFD-l 20/Division File
`
`HFD-lZO/L.Y Chen, PM
`HFD-805/N. Sweeney/Consult File
`
`
`
`Page 3 of 10
`
`
`
`
`
`7 Page(s) Withheld
`
`‘
`
`\/ § 552(b)(4) Trade Secret / Confidential
`
`§ 552(b)(5) Deliberative Process
`
`§ 552(b)(5) Draft Labeling
`
`
`
`
`
` ——-m———————————-———-——-————--muucmnm-—-—-—-—_———_—_——-—
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
` _—_—_-—_-———____-__—_------u.n—----——--—-
`
`/5/
`
`Neal Sweeney
`6/17/02 03:29:26 PM
`MICROBIOLOGIST
`
`Peter Cooney
`6/17/02 04:05:04 PM
`MICROBIOLOGIST
`
`RWEQ‘Li‘LS Tiiif’; ‘EAY
`in;
`:_,~‘,“,
`v.
`{jig GLUJHH‘ML
`
`
`
`
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