Mycophenolate mofetil

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In immunology, mycophenolate mofetil (brand name Cellcept) is an immunosuppressive agent.

History

Cellcept brand of mycophenolate mofetil was approved for Roche Palo by the Food and Drug Administration in the United States with a New Drug Application (NDA) in 1995.[1] A generic version with a AB Therapeutic Equivalence Code was approved for Sandoz with a Abbreviated New Drug Application (ANDA) in 2008.[2]

Uses

Mycophenolate mofetil is approved by the Food and Drug Administration in the United States for:

  • "prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants"

References

  1. Anonymous. Drugs@FDA for FDA Application No. 050722. U S Food and Drug Administration
  2. Anonymous. Drugs@FDA for FDA Application No. 065379. U S Food and Drug Administration