CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`022255Orig1s000
`
`MICROBIOLOGY REVIEW(S)
`
`
`
`
`
`
`
`
`
`
`
`
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`022255Orig1s000
`
`MICROBIOLOGY REVIEW(S)
`
`
`
`
`
`
`
`
`
`
`
`
`
`Product Quality Microbiology Review
`
`27 March 2010
`
`
`
`
`
`
`22-255 – Resubmission, Class 2 response
`
`
`NDA:
`
`Drug Product Name
`Proprietary:
`Lacosamide Oral Syrup
`
`Non-proprietary:
`(R) -2-acetomido-N-benzyl-3-
`methoxypropionamide
`Drug Product Priority Classification: S1
`
`2
`
`
`Review Number:
`
`
`Dates of Submission(s) Covered by this Review
`Letter
`Stamp
`Review Request
`February 18,
`2010
`
`Assigned to
`Reviewer
`February 24,
`2010
`
`Review Date(s)
`May 31, 2008
`
`October 16, 2009 October 17, 2009
`
`
`Submission History (for amendments only)
`Submit Date(s)
`Microbiology Review #
`September 28, 2007
`1
`
`
`
`Applicant/Sponsor
`Name:
`
`
`Address:
`
`Representative:
`Telephone:
`
`
`
`Name of Reviewer:
`
`Conclusion:
`
`
`
`
`
`
`
`Schwarz Biosciences
`P.O.Box 110167, Research Triangle Park, NC
`27709
`Susan Tegtmeyer, Senior Manager, Reg. Affairs
`770-970-8654 (phone), 770-970-8345 (fax)
`
`Vinayak B. Pawar, Ph.D.
`
`The application is recommended for approval from
`microbiology product quality standpoint.
`
`
`
`NDA 22-255 Resubmission
`
`
`Microbiology Review # 2
`
`
`
`
`Product Quality Microbiology Data Sheet
`1.
`TYPE OF SUBMISSION:
`Original NDA
`
`2.
`
`SUBMISSION PROVIDES FOR: A change
`reformulated oral solution.
`
`MANUFACTURING SITE:
`Schwarz Pharma Manufacturing Inc.,
`1101 C Avenue West, Seymour, IN 47274.
`
` in the
`
`
`A.
`
`B.
`
`C.
`
`3.
`
`
`4.
`
`
`5.
`
`6.
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`10mg/mL
`
`METHOD(S) OF STERILIZATION:
`
`
`
`PHARMACOLOGICAL CATEGORY: For treatment of partial-onset
`seizures.
`
`
`SUPPORTING/RELATED DOCUMENTS: NDA 22-253 & NDA 22-255
`
`REMARKS: The Re-submitted NDA 22-255 (October 16, 2009) is intended to
`be a full response to the FDA’s complete response letter dated October 28, 2008.
`Although there were no microbiology product quality deficiencies in the original
`submission, the re-submission is being reviewed due to changes made
`
`. During the review of the Lacosamide oral solution application
`in Europe, the EMEA requested the removal of
` from the
`formulation (June 2008). For consistency, it was also removed from the proposed
`US formulation. Therefore, in the re-submission, the reformulation of the oral
`syrup Lacosamide (SPM927) includes removal of
` and a change in
` level. The re-submission is in electronic format in EDR. Initial
`Quality Assessment has been filed by Martha Heinman on October 30, 2007. No
`IQA was filed for the re-submission.
`
`
`
`filename: C:\my documents\review\supplement\N022255R2
`
`
`
`
`
`
`
`Page 2 of 8
`
`
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`
`
`NDA 22-255 Resubmission
`
`Executive Summary
`
`
`
`
`
`Microbiology Review # 2
`
`
`I.
`
`II.
`
`
`Recommendations
`
`A.
`
`Recommendation on Approvability – The re-submission is
`recommended for approval from microbiology product quality
`standpoint.
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable - NA
`
`B.
`
`
`Summary of Microbiology Assessments
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology –
`
`
`
`B.
`
`C.
`
`III. Administrative
`
`
`The resubmission has a change in formulation
`
`
`
`
`Brief Description of Microbiology Deficiencies – None.
`
`Assessment of Risk Due to Microbiology Deficiencies – None.
`
`A.
`
`
`
`B.
`
`C.
`
`Reviewer's Signature ___________________________________
`
`
` Primary Reviewer, Vinayak B. Pawar, Ph.D.
`
`Endorsement Block ____________________________________
` Secondary concurrence, Bryan S. Riley, Ph.D.
`
`
`CC Block
`N/A
`
`
`
`
`
`
`
`Page 3 of 8
`
`
`
`(b) (4)
`
`(b) (4)
`
`5 Pages have been Withheld in Full immediately
`following this page as B4 (CCI/TS)
`
`(b) (4)
`
`
`
`Application
`Type/Number
`--------------------
`NDA-22255
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`SCHWARZ
`BIOSCIENCES INC
`
`------------------------------------------
`VIMPAT
`
`---------------------------------------------------------------------------------------------------------
`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
`03/30/2010
`
`BRYAN S RILEY
`03/31/2010
`I concur.
`
`
`
`
`Review Number:
`
`
`Dates of Submission(s) Covered by this Review
`Letter
`Stamp
`Review Request
`September 28,
`November 20,
`2007
`2007
`
`1
`
`October 1, 2007
`
`Assigned to
`Reviewer
`November 21,
`2007
`
`Product Quality Microbiology Review
`
`31 May 2008
`
`
`
`
`
`
`22-255
`
`
`NDA:
`
`Drug Product Name
`Proprietary:
`Lacosamide Oral Syrup
`
`Non-proprietary:
`(R) -2-acetomido-N-benzyl-3-
`methoxypropionamide
`Drug Product Priority Classification: S1
`
`
`
`Submission History (for amendments only) - N/A
`
`
`
`Applicant/Sponsor
`Name:
`
`
`Address:
`
`Schwarz Biosciences
`P.O.Box 110167, Research Triangle Park, NC
`27709
`Alan L. Blumberg, Sr. Dir. Global Reg. Affairs
`919-767-2513 (phone), 919-767-3139 (fax)
`
`Vinayak B. Pawar, Ph.D.
`
`The application is recommended for approval from
`microbiology product quality standpoint.
`
`Representative:
`Telephone:
`
`
`
`Name of Reviewer:
`
`Conclusion:
`
`
`
`
`
`
`
`
`
`
`
`A.
`
`B.
`
`C.
`
`3.
`
`
`4.
`
`
`5.
`
`6.
`
`NDA 22-255
`
`
`Microbiology Review # 1
`
`
`
`
`Product Quality Microbiology Data Sheet
`1.
`TYPE OF SUBMISSION:
`Original NDA
`
`2.
`
`SUBMISSION PROVIDES FOR: An Oral form of a drug previously
`approved in a tablet form.
`
`MANUFACTURING SITE:
`Schwarz Pharma Manufacturing Inc.,
`1101 C Avenue West, Seymour, IN 47274.
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`10mg/mL
`
`METHOD(S) OF STERILIZATION:
`
`
`
`PHARMACOLOGICAL CATEGORY: For treatment of partial-onset
`seizures.
`
`
`SUPPORTING/RELATED DOCUMENTS: NDA 22-253 & NDA 22-255
`
`REMARKS: The consult requests review of an original NDA 22-255 for an oral
`syrup form of Lacosamide (SPM927). This application is a GRMP pilot
`application. The submission is in electronic form in EDR. Initial Quality
`Assessment has been filed by Martha Heinman on October 30, 2007.
`
`
`
`filename: C:\my documents\review\supplement\N022255R1
`
`
`
`
`
`
`
`Page 2 of 10
`
`
`
`(b) (4)
`
`
`
`NDA 22-255
`
`Executive Summary
`
`
`
`
`
`Microbiology Review # 1
`
`
`I.
`
`II.
`
`
`Recommendations
`
`A.
`
`Recommendation on Approvability – The application is
`recommended for approval from microbiology product quality
`standpoint.
`Recommendations on Phase 4 Commitments and/or
`Agreements, if Approvable - NA
`
`B.
`
`
`Summary of Microbiology Assessments
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology –
`
`
`
`B.
`
`C.
`
`III. Administrative
`
`
`Brief Description of Microbiology Deficiencies – None.
`
`Assessment of Risk Due to Microbiology Deficiencies – None.
`
`A.
`
`
`
`B.
`
`C.
`
`Reviewer's Signature _____________________________
`
`
`
`
`Vinayak B. Pawar, Ph.D.
`
`Endorsement Block _____________________________
`James McVey
`
`CC Block
`N/A
`
`
`
`
`
`
`
`Page 3 of 10
`
`
`
`
`
`(b) (4)
`
`(b) (4)
`
`7 Pages have been Withheld in Full immediately
`following this page as B4 (CCI/TS)
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Vinayak Pawar
`6/5/2008 03:35:59 PM
`MICROBIOLOGIST
`
`Recommended for approval from microbiology product quality standpoint.
`
`James McVey
`6/5/2008 03:41:32 PM
`MICROBIOLOGIST
`I concur.
`
`
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