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
2. Information Request
Author: PAULINE COTTRELL
Clarification of the Carton labeling and packaging of Wilate
[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
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.