Product Approval Information
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.
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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.