Myhibbin FDA Approval History
Last updated by Judith Stewart, BPharm on May 20, 2024.
FDA Approved: Yes (First approved May 1, 2024)
Brand name: Myhibbin
Generic name: mycophenolate mofetil
Dosage form: Oral Suspension
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Organ Transplant, Rejection Prophylaxis
Myhibbin (mycophenolate mofetil) is an antimetabolite immunosuppressant used for the prophylaxis of organ 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.
- Myhibbin contains mycophenolate mofetil which was first approved in 1995 under the brand name CellCept. CellCept is available in capsule, tablet, injection, and powder for oral suspension dosage forms. Myhibbin is a liquid formulation of mycophenolate mofetil that does not require reconstitution.
- Myhibbin is administered orally twice daily.
- Myhibbin comes with a Boxed Warning for embryofetal toxicity, malignancies, and serious infections. Warnings and precautions associated with Myhibbin include blood dyscrasias, gastrointestinal complications, hypoxanthine-guanine phosphoribosyl-transferase deficiency, and acute inflammatory syndrome. Myhibbin may affect ability to drive or operate machinery.
- Common adverse reactions include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections.
Development timeline for Myhibbin
Date | Article |
---|---|
May 6, 2024 | Approval FDA Approves Myhibbin (mycophenolate mofetil) Oral Suspension for Prophylaxis of Organ Rejection |
Further information
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