Patients Need to Switch from SangCya to Alternative Cyclosporine Product
The SangCya recall was prompted by SangStat's release of information to the Food and Drug Administration (FDA) about the product's bioavailability. The withdrawal of SangCya leaves just one cyclosporine oral solution, Novartis Pharmaceutical Corp.'s Neoral, on the U.S. market.
SangCya was approved by FDA in October 1998 under an abbreviated application indicating the product's bioavailability was equivalent to that of Neoral oral solution. However, SangStat recently informed FDA that a study conducted before October 1998 showed that SangCya is not absorbed as readily as Neoral when taken with apple juice. Because the labeling recommends that patients take SangCya with apple or orange juice, FDA asked SangStat to withdraw the product.
The recall allows pharmacies and patients to keep their existing supplies of SangCya. Wholesalers have been asked to return the drug to the manufacturer. In explaining its decision to limit the recall to wholesalers, FDA cited concerns about the effects of abruptly switching patients to a different cyclosporine product.
To help patients change from SangCya to another cyclosporine product, Novartis announced Aug. 2 that it has arranged for patients to have up to three free whole-blood cyclosporine tests through Clinical Reference Laboratory, a privately owned company in Lenexa, Kan. Novartis advises physicians interested in this offer to contact the Neoral Assurance Program at 800-797-4697.
Other than SangCya, there is no generic equivalent of Neoral oral solution available in U.S. pharmacies. Gengraf cyclosporine oral solution, a product co-promoted by SangStat and Abbott Laboratories, was approved May 12 by FDA but is not available for purchase. The only other FDA-approved generic oral cyclosporine products currently offered for sale are Gengraf capsules and a soft gelatin capsule by New York-based Eon Labs Manufacturing Inc.
According to Thomas Steffie of Novartis, patients are eligible for free blood tests even when they switch from SangCya to a cyclosporine product not manufactured by Novartis.
[4 December 2000 updateFDA announced today that it will withdraw the abbreviated new drug application for SangCya on Jan. 3, 2001. After that date, commercial distribution of the product across state lines will be illegal.]