FDA approval for Myhibbin (mycophenolate mofetil oral suspension) to protect a donated organ from being rejected from the body’s immune response – Azurity Pharma

Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced that the 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.