Record of Telephone Conversation, May 3, 2013 - RAGWITEK

Submission Type: BLA Submission ID: 125478/0 Office: OVRR
Product:
Short Ragweed Pollen Allergen Extract
Applicant:
Merck Sharp & Dohme Corp.
Telecon Date/Time: 03-May-2013 03:45 PM Initiated by FDA? Yes
Telephone Number: ---b(4)------
Communication Categorie(s):
1. Advice
Author: KATIE RIVERS

Telecon Summary:
Confirmation of PNR acceptance letter receipt and confirmation that the use of a sticker to add the proprietary name to the blister packs of their drug product launch lots is no longer required.
FDA Participants: Scott Greenfeder, Ph.D.
Non-FDA Participants: Katie Rivers, M.S.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:

I called Dr. Greenfeder to confirm that he received the faxed proprietary name review acceptance letter and to confirm that the use of a sticker to add the proprietary name to the blister packs of their drug product launch lots is no longer required. Dr. Greenfeder confirmed that they will print the blister packs with the accepted proprietary name and that a sticker is no longer required. Dr. Greenfeder also stated that they will re-submit labeling documents with the updated proper and proprietary name within the next couple of weeks.

We thanked each other and the call ended.
