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CellCept News
FDA Approves Expansion of CellCept (mycophenolate mofetil) Indication to Pediatric Heart Transplant and Pediatric Liver Transplant Populations
June 8, 2022 – FDA has expanded the use of CellCept (mycophenolate mofetil) to prophylaxis of organ rejection in pediatric recipients of allogenic heart and allogeneic liver transplants aged 3...
FDA Medwatch Alert: Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection, USP Due to the Presence of a Glass Fragment Observed in One Vial of Reconstituted Product
Endo International plc, announced today that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling one lot of Mycophenolate Mofetil for Injection, USP to the hospital and...
FDA Medwatch Alert: CellCept (mycophenolate mofetil) - Feb 12, 2009
[Posted 02/12/2009] FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients...
FDA Medwatch Alert: Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)
[Posted 05/16/2008] FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during...
FDA Medwatch Alert: CellCept (mycophenolate mofetil) - Oct 29, 2007
[Posted 10/29/2007] Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of...
FDA Medwatch Alert: CellCept (mycophenolate mofetil) - Feb 22, 2007
Indication: Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants [Posted 02/22/2007] Roche and FDA notified cardiac transplant healthcare...
FDA Medwatch Alert: Immunosuppressant Drugs: Required Labeling Changes
Sirolimus (marketed as Rapamune), Cyclosporine (marketed as Sandimmune and generics), Cyclosporine modified (marketed as Neoral and generics), Mycophenolate mofetil (marketed as Cellcept and...
FDA Medwatch Alert: CellCept (mycophenolate mofetil), Myfortic (mycophenolate acid)
[Posted 04/10/2008] FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection,...
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