
Record of Telephone Conversation, November 17, 2010 - Anascorp

 
 
 

Submission Type: BLA    Submission ID: 125335/0    Office: OBRR

Product: Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine)

Applicant:Instituto Bioclon, S.A. de C.V.

Telecon Date/Time: 17-Nov-2010 11:00 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Advice

 

Author: DEBRA CORDARO

Telecon Summary:Discussion of Applicant Change

FDA Participants: Debbie Cordaro

Non-FDA Participants: -------(b)(4)----------

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:



The applicant indicated that a business decision was being discussed to transfer ownership of this product from Instituto Bioclon, S.A. de C.V. to Rare Disease Therapeutics, Inc. (RDT). If the transfer occurs, Instituto should submit a correspondence to this file explaining the transfer and include information how, if at all, the manufacture of the product will be affected. A revised Form FDA 356h, with the new applicant information, must be submitted. The applicant will also need to submit revised labeling that indicates RDT is the applicant.