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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  02/27/2004
Trade Name:  Myfortic Delayed-Release Tablets
Generic Name or Proper Name (*):  mycophenolic acid
Indications Studied:  Prevention of organ rejection in patients receiving allogeneic renal transplants in children 5-16 years of age with stable renal transplants
Label Changes Summary:  * Approval based on extrapolation of safety and effectiveness in adult patients * One PK study with information down to 5 years of age * Waived studies in birth to 10 years because there are too few children to study. * New active ingredient
Product Labeling:  Labeling  Opens a new window
Sponsor:  Novartis
Therapeutic Category:  Immunosuppressant