Prevents organ rejection. NDA 216482, held by Azurity. Mycophenolate Mofetil.
As of Nov 13, 2026, NDA 216482 (Myhibbin), held by Azurity, was first approved by FDA on May 1, 2024, with 4 approved supplements and 1 published complete response letter.
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 is an antimetabolite immunosuppressant 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 6, 2023 | Mycophenolate mofetilRisk Evaluation And Mitigation Strategy Requirements, Submission Of Rems Document In Spl Format | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Myhibbin200MG/ML · suspension;oral | Mycophenolate Mofetil | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2026 | Supplement 6Labeling · Standard review | Approved | |
| Jul 29, 2026 | Supplement 5REMS | Approved | |
| Jun 27, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Aug 13, 2024 | Supplement 1REMS | Approved | |
| May 1, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
