Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T00-32 Print Media: 301-827-6242
July 10, 2000
Consumer Inquiries: 888-INFO-FDA
The Food and Drug Administration today announced the nationwide recall of SangCya oral solution, a generic version of the anti-rejection drug cyclosporine (Neoral oral solution), because of clinical evidence that the generic drug's availability is reduced relative to Neoral oral solution if the drug is administered with apple juice. Patients taking cyclosporine capsules are not affected by this recall.
SangStat Medical Corporation of Fremont, California, the makers of SangCya, recently informed the FDA about a study that was completed before the approval of the application. The data from this clinical study showed that taking SangCya oral solution with apple juice diminishes its absorption relative to Neoral oral solution. Because the drug's labeling suggests that it be taken with apple or orange juice, the agency asked the sponsor to recall the product.
Since it is recognized that some patients may be adversely affected by abruptly changing from SangCya oral solution to another cyclosporine product, FDA will allow the product to remain in pharmacies and hospitals. This continued availability should allow a smooth transition of patients from the SangCya product to another cyclosporine product.
FDA is reviewing all data related to this product and will take any appropriate further steps needed to assure the safety patients. In the meantime, patients taking cyclosporine oral solution should consult with their health care provider about their treatment. Patients taking SangCya oral solution should not change how they are taking their drug without talking to their health care provider.
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