CellCept FDA Approval History
Last updated by Judith Stewart, BPharm on June 14, 2022.
FDA Approved: Yes (First approved May 3, 1995)
Brand name: CellCept
Generic name: mycophenolate mofetil
Dosage form: Tablets, Capsules, Oral Suspension, Injection
Company: Genentech, Inc.
Treatment for: Organ Transplant, Rejection Prophylaxis
CellCept (mycophenolate mofetil) 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.
- CellCept has been approved for the following indications:
- Adult kidney transplant on May 3, 1995
- Adult heart transplant on February 11, 1998
- Adult liver transplant on July 28, 2000
- Pediatric kidney transplant on December 20, 2000
- Pediatric heart transplant on June 6, 2022
- Pediatric liver transplant on June 6, 2022
- CellCept has a boxed warning for increased risks of first trimester pregnancy loss and congenital malformations. Prescribing information also notes an increased risk of development of lymphoma and other malignancies and an increased susceptibility to bacterial, viral, fungal, and protozoal infections.
- Common adverse reactions include diarrhea, leukopenia, infection, and vomiting, and there is evidence of a higher frequency of opportunistic infections.
Development timeline for CellCept
|Jun 8, 2022||Approval FDA Approves Expansion of CellCept (mycophenolate mofetil) Indication to Pediatric Heart Transplant and Pediatric Liver Transplant Populations|
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