FDA Approves Myhibbin Oral Suspension for Prophylaxis of Organ Rejection
Azurity Pharmaceuticals, has 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 U.S. 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.
- It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024.