LICENSING ACTION RECOMMENDATION
125264/0 Wyeth Pharmaceuticals Inc. Applicant: _______________________________________________________________ STN: ______________________________
Product:
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method ________________________________________________________________________________________________________
Indication / manufacturer's change :
Control and prevention of hemorrhagic episodes and surgical prophylaxis in patients with Hemophilia A.
s � Approval: � Summary Basis For Approval (SBA) included � Memo of SBA equivalent reviews included s
� Refusal to File: Memo included � Denial of application / supplement: Memo included
RECOMMENDATION BASIS
s � Review of Documents listed on Licensed Action Recommendation Report
� Inspection of establishment
s � BiMo inspections completed
� Inspection report included � BiMo report included
� Review of protocols for lot no.(s) ______________________________________________________________________________ � Test Results for lot no.(s) ____________________________________________________________________________________
s � Review of Environmental Assessment
� FONSI included � None needed
� Categorical Exclusion
s � Review of labeling
14-feb-08 Date completed ________________
CLEARANCE – PRODUCT RELEASE BRANCH
� CBER Lot release not required � Lot no.(s) in support – not for release ___________________________________________________________________________
53526, 66518, 66519 � Lot no.(s) for release ________________________________________________________________________________________ s
By Joseph Quander III at 1:55 pm, Feb 19, 2008 Joseph Quander III Director, Product Release Branch ________________________________________________________________________________
CLEARANCE – REVIEW
Timothy Lee Review Committee Chairperson: __________________________________________________________
Product Office’s Responsible Division Director(s)*:
Date: _______________ 2008 By Roman Drews at 6:57 pm, Feb 14,
Basil Golding __________________________________________________
__________________________________________________
Date: _______________
By Basil Golding at 5:38 pm, Feb 14, 2008
Date: _______________
By John A. Eltermann, at 1:00 John Eltermann DMPQ Division Director* : __________________________________________________ Jr.Date:pm, Feb 20, 2008 _______________
* If Product Office or DMPQ Review is conducted
CLEARANCE – APPLICATION DIVISION
s � Compliance status checked
s � Acceptable
� Hold � Cleared from Hold
20-Feb-08 Date: __________________
Date: __________________
� Compliance status check Not Required
Pauline Cottrell Regulatory Project Manager (RPM) __________________________________________________
By Pauline Cottrell at 2:46 pm, Feb 14, 2008
Date: __________________ Date: __________________
Elizabeth Callaghan/For Responsible Division Director ______________________________________________________ (where product is submitted, e.g., application division or DMPQ)
Form DCC-201 (05/2003)
By Jeffrey Anderson at 11:43 am, Feb 20, 2008