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 (the “Company”), issued a press release announcing that, at the time of the press release, the Company had not received any formal written communication from the U.S. Food and Drug Administration (“FDA”) regarding the Prior Approval Supplement for BIVIGAM® (Intravenous Immune Globulin [Human], 10%) under the Prescription Drug User Fee Act. When the Company receives official written communication from the FDA, the Company will promptly provide appropriate disclosures.
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 e618109_ex99-1.htm ADMA Biologics Provides Regulatory Update for BIVIGAM® FDA PDUFA Action Anticipated RAMSEY,…
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.
