FDA Approves Prior Approval Supplement for BIVIGAM ADMA Announces it will Commence Commercial Sales of BIVIGAM RAMSEY, N.J. and BOCA RATON, FL.

FDA Approves Prior Approval Supplement

ADMA Announces it will Commence Commercial

RAMSEY, N.J. and BOCA RATON, FL., - May 10, 2019 -

ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical

and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment

of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration

("FDA") has approved the Company's Prior Approval Supplement ("PAS") for BIVIGAM (immune globulin

intravenous (human), 10% liquid). The FDA's approval of the PAS for BIVIGAM approves the use of the Company's

optimized intravenous immune globulin ("IVIG") manufacturing process and enables ADMA to commence the marketing of

BIVIGAM in the U.S. to patients with Primary Humoral Immunodeficiency ("PI").

"This FDA approval for ADMA's third commercial product

is a significant milestone, and we look forward to commencing sales of BIVIGAM in the near-term," stated Adam Grossman,

President and Chief Executive Officer of ADMA. "The FDA's approval of BIVIGAM 's modified manufacturing process

validates our commitment to optimizing the ADMA IVIG manufacturing process and signifies the extensive and successful remediation

and turnaround of our Boca Raton, Florida manufacturing facility."

"We are pleased to re-introduce BIVIGAM into the

market, where demand for IVIG therapy continues to outpace supply." Mr. Grossman continued, "The $6 billion U.S. market

for IVIG continues to grow and the relaunch of BIVIGAM can help to alleviate a portion of the tight supply for this important

patient population, where dependable and consistent supply of IVIG is critical to patients' well-being."

BIVIGAM received its initial FDA approval in December 2012.

The BIVIGAM pivotal clinical study was a prospective, open-label, single-arm multicenter trial, which achieved its primary

endpoints for safety, efficacy and tolerability. The results were published by Dr. Richard Wasserman, et al. in the Journal of

Clinical Immunology in 2014. In December 2016, Biotest Pharmaceuticals Corporation ("BPC") voluntarily suspended commercial

production of BIVIGAM due to certain manufacturing and compliance issues. Subsequent to ADMA's acquisition of

the Biotest Therapy Business Unit ("BTBU") assets in June 2017, of which BIVIGAM was a part, ADMA resumed production

of BIVIGAM during the fourth quarter of 2017, successfully manufacturing three conformance lots using the Company's

optimized IVIG manufacturing process. ADMA anticipates the re-launch of BIVIGAM for commercial sale during the second half

ADMA Biologics, Inc. (ADMA)

ADMA Biologics is a vertically integrated biopharmaceutical

manufacturer with three FDA approved commercial specialty plasma-based biologics. ADMA's mission is to develop and commercialize

plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious

diseases and management of immune compromised patient populations. The target patient populations include immune compromised individuals

who suffer from an underlying immune deficiency disease, or who may be immune compromised for other medical reasons. ADMA has

received U.S. Patents 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and

product candidates. For more information, please visit www.admabiologics.com.

About Primary Immune Deficiency Disease ("PI")

PI is a class of inherited genetic disorders that causes an

individual to have a deficient or absent immune system. According to the World Health Organization, there are approximately 350

different genetic mutations encompassing PI. Some disorders present at birth or in early childhood, the disorders can affect anyone

regardless of age or gender. Some affect a single part of the immune system, others may affect one or more components of the system.

PI patients are vulnerable to infections and more likely to suffer complications from these

infections as compared to individuals with a normal functioning immune system. The infections may occur in any part of the

body. Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with

polyclonal immune globulin products. Without this exogenous antibody replacement, these patients would remain vulnerable to persistent

and chronic infections. PI has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people in the

BIVIGAM is an immune globulin intravenous (human), 10%

liquid, indicated for the treatment of primary humoral immunodeficiency. This includes, but is not limited to, X-linked and congenital

agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. These PIs

are a group of genetic disorders. Initially thought to be very rare, it is now believed that as many as 250,000 people in the U.S.

have some form of PI. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies

are directed against bacteria and viruses, and help to protect PI patients against serious infections. BIVIGAM is a purified,

sterile, ready-to-use preparation of concentrated human Immunoglobulin ("IgG") antibodies. Antibodies are proteins

in the human immune system that work to defend against infections and disease. FDA's initial approval for BIVIGAM was

received by BPC in December 2012, and production of BIVIGAM was halted by BPC in December 2016. ADMA obtained ownership and

all rights, title and interest in BIVIGAM in June 2017 as part of the Biotest Therapy Business Unit ("BTBU") asset

acquisition and resumed the production of BIVIGAM during the fourth quarter of 2017. Using ADMA's optimized IVIG manufacturing

process, FDA approved a PAS to amend the BLA for the product on May 9, 2019 allowing the Company to resume the supply of drug to

Additional Important Safety Information

for BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid]

BIVIGAM [Immune Globulin

Intravenous (Human), 10% Liquid] is indicated for the treatment of primary humoral immunodeficiency (PI). This includes, but is

not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia,

Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

BIVIGAM is contraindicated in patients

who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients

with antibodies to IgA and history of hypersensitivity.

Thrombosis may occur following treatment

with IGIV products, including BIVIGAM. Thrombosis may occur in the absence of known risk factors.

Consider baseline assessment of blood

viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/ markedly high triacylglycerols

(triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer BIVIGAM at the minimum dose and infusion

In patients at risk of developing acute

renal failure, renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output need to be monitored.

Hyperproteinemia, increased serum viscosity,

and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy. Aseptic meningitis syndrome (AMS) has been

reported with IGIV treatments; AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.

As hemolysis can develop subsequent

to treatment with IGIV products, monitor patients for hemolysis and hemolytic anemia. Monitor patients for pulmonary adverse reactions

(transfusion-related acute lung injury [TRALI]). If TRALI is suspected, test the product and patient for antineutrophil antibodies.

Because BIVIGAM is made from human

blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD)

Passive transfer of antibodies with

IGIV treatment may yield positive serological testing results, with the potential for misleading interpretation.

Serious adverse reactions observed

in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to

BIVIGAM (reported in 5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood

pressure increase, diarrhea, dizziness, and lethargy.

You are encouraged to report negative

side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

For more information about BIVIGAM,

please see full Prescribing Information.

You are encouraged to report side

effects of prescription drugs to ADMA Biologics @ 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements"

pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. ("we",

"our" or the "Company"). Forward-looking statements include, without limitation, any statement that may

predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate,"

"project," "intend," "forecast," "target," "anticipate," "plan,"