Azurity Pharmaceuticals secures FDA approval for Myhibbin oral suspension 

USA -Azurity Pharmaceuticals,  proudly announced the FDA’s approval of Myhibbin™, the first ready-to-use mycophenolate mofetil oral suspension.

Mycophenolate mofetil serves as a crucial antimetabolite immunosuppressant, shielding transplanted organs from rejection by the recipient’s immune system. 

With over 46,000 transplant procedures performed in the United States in 2023 alone, the necessity for daily medication to avert rejection reinforces the significance of Myhibbin’s approval. 

It’s specifically indicated for the prophylaxis of organ rejection in both adult and pediatric recipients aged three months and older who have undergone allogeneic kidney, heart, or liver transplants, typically in conjunction with other immunosuppressive agents.

Richard Blackburn, CEO of Azurity Pharmaceuticals, expressed enthusiasm over the approval, stating,“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.” 

Blackburn emphasized Azurity’s unwavering commitment to patient welfare, affirming that Myhibbin’s user-friendly formulation offers patients, pharmacists, and caregivers a convenient alternative to existing mycophenolate dosage forms.

Commercial availability of Myhibbin in pharmacies across the United States is anticipated in the second quarter of 2024. 

Myhibbin’s approval represents a breakthrough in transplant medicine, providing a vital therapeutic option for individuals navigating the intricate post-transplant landscape. 

“ When you get a kidney transplant, your body knows that the new kidney is foreign (that is, not originally part of your body).”

”Your body will attack the new kidney and try to damage or destroy it. The immunosuppressant drugs suppress your body’s ability to do this,” reports the National Kidney Foundation. “The goal is to adjust these drugs to prevent rejection and to minimize any side effects of the drugs.”

Even a single missed dose could precipitate rejection,  emphasizing the critical importance of adherence to prescribed medication regimens. 

Recognizing the diversity of drugs employed post-transplantation, Myhibbin emerges as a welcome addition to the armamentarium of immunosuppressive agents, tailored to meet the specific needs of transplant recipients.

The approval of Myhibbin comes on the heels of Azurity Pharmaceuticals’ proactive response to quality assurance concerns, exemplifying the company’s steadfast commitment to product integrity and patient safety.