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Article: FDA Recalls SangCya Oral Solution, Generic Version of Cyclosporine.
- Article from:
- Blood Weekly
- Article date:
- July 27, 2000
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2000 JUL 27 - (NewsRx.com) --
The U.S. Food and Drug Administration announced on July 10 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 ...