`
`APPROVAL PACKAGE FOR:
`
`APPLICATION NUMBER
`
`21-372
`
`Microbiology Review(s)
`
`
`
`Product Quality Microbiology Review
`Review for HFD-180
`
`May 12, 2003
`
`NDA: 21-372
`
`Drug Product Name
`Proprietary:
`Non-proprietary: Palonosetron Hydrochloride Injection
`Drug Product Classification: anti emetic
`
`Review Number: 1
`
`Subject of this Review
`Submission Date: September 26, 2002
`Receipt Date:
`Consult Date: October 25, 2003
`
`Date Assigned for Review: November 7, 2002
`
`Submission History (for amendments only):
`
`.
`Applicant/Sponsor
`Name:
`Helsinn Healthcare SA
`
`Address:
`
`Via Plan Scairolo
`
`6912 Pazzallo (Lugano) - Switzerland
`Representative:
`_
`Telephone:
`Authorized Agent: Dr. Craig Lehmann
`'
`August Consulting Inc.
`515 Capitol of Texas Highway, Suite 150
`Austin, TX 78746
`-
`
`(512) 347-1755
`
`Name of Reviewer:
`
`James L. McVey
`
`Conclusion: This application is recommended for approval from a product
`quality microbiology perspective.
`
`
`
`NDA 21—372
`
`Microbiology Review #1
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`l.
`
`2.
`
`3.
`
`_ TYPE OF SUPPLEMENT:
`
`SUPPLEMENT PROVIDES FOR:
`
`MANUFACTURING SITE: The drug product will be manufactured,
`tested for release and for stability and released for commercial use by:
`
`\
`
`Vs
`
`Additional testing site:
`
`.—
`
`_
`-
`Additional ..
`Helsinn Birex Pharmaceuticals Ltd.
`Damastown
`Mulhuddart — Dublin 15
`Ireland
`
`‘ site:
`
`4.
`
`5.
`
`6.
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY: 0.25 mg/ 5 mL vial for intravenous
`administration.
`
`METHOD(S) OF STERILIZATION: The product is
`followed by '-
`\—-
`fisterilization"
`
`——'——
`
`PHARMACOLOGICAL CATEGORY: anti emetic
`
`B.
`
`INC/RELATED DOCUMENTS:
`SUPP,
`DMF [16063 for drug substance — not reviewed for product quality microbiology.
`
`C.
`
`REMARKS: Well organized and assembled application.
`
`filename: 21372rl
`
`/—.\
`
`Page 2 of8
`
`
`
`NDA 21-372
`
`Microbiology Review #1
`
`Executive Summary
`
`1.
`
`Recommendations
`
`- A.
`
`Recommendation on Approvability — This application is
`recommended for approval from a product quality microbiology
`perspective.
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable -
`
`II.
`
`Summary of Microbiology Assessments
`
`A.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology — The product is \_ sterilized
`—
`to _
`
`
`v _ sterilized with a validated
`
`~j
`
`fi\
`
`B.
`
`C.
`
`Brief Description of Microbiology Deficiencies — None.
`
`Assessment of Risk Due to Microbiology Deficiencies — Minimal
`risk is seen from a product quality microbiology perspective.
`
`lIl.
`
`Administrative
`
`A.
`
`B.
`
`C.
`
`Reviewer's Signature
`
`Endorsement Block
`
`Review Microbiologist. J.L. McVey
`Microbiology Supervisor. PH. Cooney
`
`CC Block
`cc:
`
`DFS
`
`HFD- 805/McVey/21372r1
`
`Page 3 of 8
`
`
`
`
`
` : RedéCted f7_.
`
`pages of trade
`
`
`
`--------------------------*n-c-Dou-uboun-I-I---------------a-------n-n-I-n-n-I-n-n-n-n-I-uh-----------------------u
`
`This'Is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`/8/
`
`James McVey'
`5/28/03 11:10:31 AM
`MICROBIOLOGIST
`
`Peter Cooney
`5/29/03 09:05:23 AM
`MICROBIOLOGIST
`
`
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
