Azurity Pharmaceuticals, a pharmaceutical company specializing in innovative dose forms and formulations to address the needs of underserved patient populations, has announced that the US Food and Drug Administration (FDA) has approved Myhibbin™, marking the first ready-to-use mycophenolate mofetil oral suspension available in the market.

Mycophenolate mofetil, an antimetabolite immunosuppressant crucial in safeguarding transplanted organs from rejection by the body's immune system, is a vital medication for organ transplant recipients. In the United States alone, over 46,000 transplants were conducted in 2023, highlighting the substantial demand for medications to prevent organ rejection.

Myhibbin™ is indicated for the prophylaxis of organ rejection in both adult and pediatric recipients, aged 3 months and older, of allogeneic kidney, heart, or liver transplants. It is intended to be used in combination with other immunosuppressants.

Richard Blackburn, CEO of Azurity Pharmaceuticals, expressed his satisfaction with the FDA approval, emphasizing the company's commitment to patient-centric innovation. He stated, "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. Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines."

The ready-to-use formulation of Myhibbin™ offers a convenient alternative for patients, pharmacists, and caregivers compared to other mycophenolate dosage forms. Its approval represents a significant advancement in providing accessible and user-friendly medication options for transplant recipients.

Myhibbin™ is slated to be commercially available in pharmacies nationwide in the second quarter of 2024, providing much-needed relief and convenience to organ transplant recipients across the country.