WOBURN, Mass., May 6, 2024
/PRNewswire/ -- Azurity Pharmaceuticals, a pharmaceutical company
focused on developing innovative dose forms and formulations of
products to serve the needs of overlooked patients, announced today
that the U.S. Food and Drug Administration (FDA) has approved
Myhibbin™, the only ready-to-use mycophenolate mofetil
oral suspension. Mycophenolate mofetil is an antimetabolite
immunosuppressant used to protect a donated organ from being
rejected from the body's immune response. In 2023, there were over
46,000 transplants in the US and these patients need to take
medication every day to fight against rejection. Myhibbin is
indicated for the prophylaxis of organ rejection in adult and
pediatric recipients 3 months of age and older of allogeneic
kidney, heart, or liver transplants, in combination with other
immunosuppressants.
"We are very pleased that adult and pediatric organ transplant
recipients will soon have access to the only FDA-approved
ready-to-use oral liquid formulation of mycophenolate,"
said Richard Blackburn, CEO of Azurity Pharmaceuticals.
"Patients are our priority, and our purpose is to bring them new
formulations that help them benefit from established medicines.
Myhibbin's ready-to-use formulation provides patients, pharmacists,
and caregivers an alternative to other mycophenolate dosage
forms."
It is expected that Myhibbin will become commercially available
in pharmacies nationwide in Q2 2024. For full prescribing
information including black box warning, please go to
www.Myhibbin.com.
About Azurity Pharmaceuticals, Inc.
Azurity specializes in providing innovative, high-quality medicines
that serve overlooked patients. We supply a large number of
products to treat a wide range of medical conditions. These include
cardiovascular, central nervous system, endocrine,
gastro-intestinal, anti-infective and oncology medicines. Many of
our medicines are dose-form innovations for patients with needs
that are not met by other available products. Our medicines have
benefited millions of people. For more information,
visit www.azurity.com.
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SOURCE Azurity Pharmaceuticals