Mid-Cycle Meeting Memo - XYNTHA

MEMORANDUM

Food and Drug Administration
 Center for Biologics Evaluation and Research


Date: 

Oct. 1, 2007 


From: 

Pauline Cottrell, CBER/OBRR/DBA, and HFM-380 


Meeting Date: 

Sept. 26, 2007 


Time: 

10:00 AM - 11:00 AM EST 


Location: 

Room WOC 200 S 

Type of Meeting: Mid-Cycle meeting STN: 125624/0
Sponsor: Wyeth Pharmaceuticals
Product: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method

CBER Participants:
 Pauline Cottrell
 Timothy Lee- SL
 Nisha Jain
 Paul Buehler
 Iftekhar Mahmood
 Catherine Miller
 Jean Makie
 Bhanu Kannan

Background:

BLA- New improved manufacturing process for the drug substance. ----------------------
 --------------------------------------------------------------------------------------------------------------------------

Meeting Minutes:

CMC
•Tim Lee presented his summary for the Mid Cycle review to the attendees.
•No major changes in the manufacture process, minor changes in the closure system.
•Manufacture site is in --------- by ---------. Final product is in ------------.

Clinical:
•Nisha Jain stated the Phase II trial has met safety and efficacy requirements.
•Nisha noted that the previous products name "Refacto" should not be used in reference to the new product.
•It was noted that the indication for prophylaxis is acceptable but treatment of --------------------------------------------------- is not an acceptable indication.

Clinical Pharmacology:
•Iftekhar Mahmood stated that from a pharmacokenetics perspective, this study is acceptable.
•In the clinical Pharmacology labeling section, Iftekhar has changes that he requested be faxed to the applicant.

Statistics

Boris Zalsavksy was not present but his memo stated that there were no issues.

Non Clinical

Paul Buehler has no issues from a pharmacology and toxicology perspective.

Facilities

Daniel Kearns has no issues at this time.

BIMO

Bhanu Kannan reported that inspection assignments were made to 3 clinical investigators. The inspections are still pending.

Promotional Labeling:

Cathy Miller and Jean Makie informed reviewers that they have not yet received the promotional labeling.

Action Items:

A fax will be sent informing the applicant of labeling changes that were requested.
