Filing Meeting Summary, October 11, 2012 - RIXUBIS
Subject: Filing Meeting Summary for STN 125446/0 Baxter Healthcare Corporation _Coagulation factor IX (recombinant) _ Original BLA
Location: CBER Conf. WOC 1 583
Start: Thu 10/11/2012 11:00 AM
End: Thu 10/11/2012 12:00 PM
Required Attendees: Thompson, Edward; Ovanesov, Mikhail V.; Amin, Pankaj (Pete); Campbell, Karen M; Hu, Jiang (Jessica) (CBER); Jordan, Carla; Mahmood, Iftekhar; Nguyen, Loan; Omokaro, Stephanie; Shields, Mark; Drews, Roman T; Baer, Bethany
Optional Attendees: Lee, Timothy; Jain, Nisha; Golding, Basil; Chazin, Howard; Mintz, Paul; Farshid, Mahmood; Valencia, Iliana
Resources: CBER Conf. WOC 1 583
Applicant: Baxter Healthcare Corporation
Product: Coagulation factor IX (recombinant)
Short Summary: Routine prophylaxis, perioperative management, control and prevention of bleeding episodes in patients –b(4)---- and older with hemophilia B.
We are holding the filing meeting for STN# 125446/0 in WOC 1 Rm 583. The purpose of this meeting is to:
- Identify Refuse to File (RTF) issues or if a Deficiencies Identified letter is required.
No filing issues or deficiencies identified at this time.
- Identify any required material that may have been omitted from the submission.
- Identify any substantive deficiencies or issues that may potentially have significant impact on your ability to complete this review or approve the application.
None identified at this time.
- Obtain comments from you regarding whether this submission can be filed.
All reviewers in agreement the application is filable
- APLB reviewer comments on existence of a Proprietary Name Review
The proprietary name submitted during IND phase, --b(4)------, was found unacceptable. The sponsor is being notified of the decision and will have to submit an alternative name for review under this BLA.
- Propose the product would be subject to Lot Release Surveillance or Exempt from Lot Release.
Decision will be discussed in future meeting. The product is a recombinant product and surveillance protocol will be discussed at a later time.
- Decision for the Priority Review request
Denied. Product does not qualify for priority review.
Please respond to this email thread and it will be used as meeting record.
Edward M. Thompson
Regulatory Project Manager
Office of Blood Research and Review
Division of Blood Applications
301-827-9167, Fax 301-827-2857
1401 Rockville Pike, Room 554N
Rockville, MD 20852-1448