FDA Approves Myhibbin (mycophenolate mofetil) Oral Suspension for Prophylaxis of Organ Rejection


Myhibbin (mycophenolate mofetil)


WOBURN, Mass. May 6, 2024 -- 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

Posted: May 2024

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