Product Approval Information
MEMORANDUM
| Date: | 6-Jun-07 |
| From: | Pauline Cottrell, DBA, HFM-380 |
| RE: | Filing Meeting Summary for STN:125264/0 |
| ATTENDEES: | Pauline Cottrell, Tim Lee, Nisha Jain, Paul Buehler, Iftekhar Mahmood, Boris Zaslavsky, Catherine Miller, Bhanu Kannan, Daniel Kearns |
| Sponsor: | Wyeth |
| Product: | Antihemophilic Factor (Recombinant), Plasma/Albumin Free |
| DUE DATE: | 22-Feb-08 |
| TO: | File |
The SL indicated to me that STN: 125264/0 Antihemophilic Factor (Recombinant), Plasma/Albumin-free from Wyeth requesting CBER to eliminate the use of animal-and human-derived proteins resulting in the development of the ReFacto AF manufacturing process, may be filed. He may later request additional clarification of some of the information/data submitted.