Record of Telephone Conversation - Wilate, December 3, 2009

System Info - 112648  COTTRELL, PAULINE   03-Dec-2009 14:34:44  COTTRELL

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125251/0    Office: OBRR  

Product: von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Applicant:  Octapharma Pharmazeutika Produktionsges.m.b.H

Telecon Date/Time:  03-DEC-2009 10:30 AM               Initiated by FDA?  No

Telephone Number:  866-380-4181

Communication Categorie(s):

1. Advice

2. Information Request

Author:  PAULINE COTTRELL

Telecon Summary:
Clarification of the Carton labeling and packaging of Wilate

FDA Participants: 

Pauline Cottrell
Timothy Lee
Loan Nguyen

Non-FDA Participants:  

Stan Ammons
Barbara Rangetiner
Xenia Serro
Olaf Walter
John Strell

Telecon Body:

[FDA requested a telecon to discuss the email sent by Octapharma on December 2, 2009 at 10:30 am (see attachment). FDA explained that there are concerns that the two different cartons which are linked together with a plastic band could become separated in handling.

Octapharma assured FDA that there have been no complaints or incidences reported, using this packaging format. There are not reports that these two cartons have separated before use. This is the same format used for the product distributed in other parts of the world and have been this way for some time.

Dr. Lee asked that on the cartons containing the drug product they should label it as the proper name, von Willebrand Factor/Coagulation Factor VIII Complex (Human) not von Willebrand Factor / Human Coagulation Factor VIII (Powder for intravenous injection

Octapharma agreed.

Also Dr. Lee asked that on the same carton that instead of to be reconstituted with sterile diluent (Water for Injection with 0.1% Polysorbate 80), Octapharma specify the volume, i.e. to be reconstituted with 5ml sterile diluent (Water for Injection with 0.1% Polysorbate 80)for the 450 IU/vial dose and to be reconstituted with 10ml sterile diluent (Water for Injection with 0.1% Polysorbate 80) for the 900 IU/vial dose.

Octapharma agreed.  They said they would email the revisions to Pauline Cottrell shortly and send the final drafts with the PI in SPL by FedEx tomorrow.

End