Mycophenolate mofetil: Difference between revisions
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imported>Robert Badgett (Created page with "In immunology, '''mycophenolate mofetil''' (brand name '''Cellcept''')is an immunosuppressive agent. ==History== Cellcept brand of mycophenolate mofetil was approved for...") |
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In [[immunology]], '''mycophenolate mofetil''' (brand name '''Cellcept''')is an [[immunosuppressive agent]]. | In [[immunology]], '''mycophenolate mofetil''' (brand name '''Cellcept''') is an [[immunosuppressive agent]]. | ||
==History== | ==History== | ||
Cellcept brand of mycophenolate mofetil was approved for Roche Palo by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 1995.<ref>{{FDA-Drug_Details|050722}}</ref> A generic version with a AB [[Food and Drug Administration/Catalogs/Therapeutic Equivalence Code|Therapeutic Equivalence Code]] was approved for Sandoz with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2008.<ref>{{FDA-Drug_Details|065379}}</ref> | Cellcept brand of mycophenolate mofetil was approved for Roche Palo by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 1995.<ref>{{FDA-Drug_Details|050722}}</ref> A generic version with a AB [[Food and Drug Administration/Catalogs/Therapeutic Equivalence Code|Therapeutic Equivalence Code]] was approved for Sandoz with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2008.<ref>{{FDA-Drug_Details|065379}}</ref> | ||
==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== | ==References== | ||
<references/> | <references/> | ||
Revision as of 20:29, 27 November 2012
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
- ↑ Anonymous. Drugs@FDA for FDA Application No. 050722. U S Food and Drug Administration
- ↑ Anonymous. Drugs@FDA for FDA Application No. 065379. U S Food and Drug Administration