Posted by Michael Wonder on 07 Jan 2019
ADMA Biologics submits response and provides supplemental information to FDA for Bivigam complete response letter
7 January 2019 - ADMA Biologics announces that the Company has submitted responses to the U.S. FDA complete response letter received on 19 December 2018 for Bivigam's (intravenous immune globulin [human], 10%) prior approval supplement.
The Company anticipates receiving an acknowledgement letter from the FDA within 30 days, and plans to provide appropriate updates on the progress of the Bivigam prior approval supplement review.
