ADMA BIOLOGICS, INC. (NASDAQ:ADMA) Files An 8-K Other Events
Item 8.01 Other Events.
On December 19, 2018, ADMA Biologics, Inc., a Delaware corporation, issued a press release announcing that the U.S. Food and Drug Administration has issued a Complete Response Letter for the drug substance Prior Approval Supplement (“PAS”) submission for BIVIGAM® (Intravenous Immune Globulin [Human], 10%) (“BIVIGAM®”) and previously approved the drug product PAS submission for BIVIGAM®.
The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
ADMA BIOLOGICS, INC. Exhibit
EX-99.1 2 e618110_ex99-1.htm ADMA Biologics Provides Regulatory Update on BIVIGAM® PAS Submissions FDA Issues Complete Response Letter for PAS Drug Substance,…
To view the full exhibit click here
About ADMA BIOLOGICS, INC. (NASDAQ:ADMA)
ADMA Biologics, Inc. is a late-stage biopharmaceutical company that develops, manufactures and intends to market specialty plasma-based biologics for the treatment and prevention of infectious diseases. The Company is engaged in the development and commercialization of human plasma and plasma-derived therapeutics. Its segments include Plasma Collection Centers, which includes its operations in Georgia; Research and Development, which includes its plasma development operations in New Jersey, and Corporate. Its targeted patient populations are immune-compromised individuals suffering from an underlying immune deficiency disorder or may be immune-suppressed for medical reasons. Its product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients at risk of contracting infectious diseases. Its intravenous immunoglobulin product candidate, RI-002, is intended for the treatment of primary immune deficiency disease.
