Posted by Michael Wonder on 31 Jul 2016
ADMA Biologics receives complete response letter from FDA for pending biologics license application
29 Jul 2016 - ADMA Biologics announced that the U.S. FDA has issued a complete response letter to the company’s biologics license application for RI-002, an intravenous Immunoglobulin, for the treatment of patients with primary humoral immunodeficiency disease.
The complete response letter did not cite any concerns with the clinical safety and efficacy data for RI-002 submitted by ADMA in the application nor has the FDA requested any additional clinical studies be conducted prior to FDA approval of RI-002 for primary humoral immunodeficiency disease.
