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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.