`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 22-253 & 22-254
`
`MICROBIOLOGY REVIEW! S!
`
`
`
`Product Quality Microbiology Review
`
`1 June 2008
`
`NDA:
`
`22—254
`
`Drug Product Name
`Lacosamide
`Proprietary:
`(R) -2-acetomido-N-benzyl—3-
`Non-proprietary:
`methoxypropionamide
`Drug Product Priority Classification: 81
`
`Review Number:
`
`1
`
`Dates of Submission(s) Covered by this Review
`Letter
`Stamp
`Review Request
`
`.
`Assrgned to
`Rev1ewer
`
`September 28,
`2007
`
`October 1, 2007
`
`November 20,
`2007
`
`November 21,
`2007
`
`Submission History (for amendments only) — N/A
`
`Applicant/Sponsor
`Name:
`
`Address:
`
`Schwarz Biosciences
`
`P.O.B0X 1101.67, Research Triangle Park, NC
`27709
`
`Representative:
`Telephone:
`
`Alan L. Blumberg, Sr. Dir. Global Reg. Affairs
`919—767—25 13 (phone), 919-767-3139 (fax)
`
`Name of Reviewer:
`
`Vinayak B. Pawar, Ph.D.
`
`Conclusion:
`
`The application is recommended for approval from
`microbiology product quality standpoint.
`
`
`
`NDA 22-254
`
`Microbiology Review # 1
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`2.
`
`TYPE OF SUBMISSION:
`
`Original NDA
`
`SUBMISSION PROVIDES FOR: An injectable form of a drug
`previously approved in a tablet form.
`
`{.
`
`MANUFACTURING SITE: -
`
`
`I. _’—"”'\
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`
`STRENGTH/POTENCY:
`
`10mg/mL
`
`METHOD(S) OF STERILIZATION:
`
`
`
`PHARMACOLOGICAL CATEGORY: For treatment of partial-onset
`seizures.
`
`B.
`
`C.
`
`SUPPORTING/RELATED DOCUMENTS: NDA 22—253 2 5
`
`REMARKS: The consult requests review of an original NDA 22-254 for an
`injectable form of Lacosamide (SPM927) Injection. 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\NDA\N022254R1
`
`M4}
`
`M4)
`
`23(4)
`
`APPEARS THIS WAY
`0N ORIGINAL
`
`Page 2 of 17
`
`
`
`NDA 22-254
`Microbiology Review # 1
`
`
`Executive Summary
`
`1.
`
`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 - NA
`
`11.
`
`Summary of MicrobiologyAssessments
`
`A.
`
`B.
`
`C.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology — N
`/
`.
`/
`I
`/
`v /
`//
`(
`
`_
`
`,
`
`51(4)
`
`Brief Description of Microbiology Deficiencies — None.
`
`Assessment of Risk Due to Microbiology Deficiencies — None.
`
`III.
`
`Administrative
`
`A.
`
`B.
`
`C.
`
`Reviewer's Signature
`
`Vinayak B. Pawar, Ph.D.
`
`Endorsement Block
`
`CC Block
`N/A
`
`James McVey
`
`——-————————-—_———_—_—
`
`Page 3 of 17
`
`
`
`-_
`
`M‘- Page(s) Withheld
`
`/Trade Secret/Confidential (b4)
`
`Draft Labeling (b4) i
`
`‘ Draft Labeling (b5)
`
`Deliberative Process (b5)
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Vinayak Pawar
`6/4/2008 03:09:05 PM
`MICROBIOLOGIST
`
`The application is recommended for approval from microbiology product
`quality standpoint.
`
`James McVey
`6/4/2008 03:13:31 PM
`MICROBIOLOGIST
`I concur
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
