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Monday May 15

SOURCE: Abbott Laboratories

U.S. FDA Approves Abbott's Gengraf(TM) (Cyclosporine) Capsules for The Prevention Of Organ Rejection in Kidney, Liver and Heart Transplants

- Abbott and SangStat to Co-Promote a Lower-Cost Alternative, Gengraf, in the $480 Million U.S. Cyclosporine Market -

ABBOTT PARK, Ill., and FREMONT, Calif., May 15 /PRNewswire/ -- Abbott Laboratories and SangStat, The Transplant Company®, announced today the United States Food and Drug Administration (FDA) approval to market Abbott's Gengraf(TM) capsules (cyclosporine capsules, USP [MODIFIED]), an immunosuppressant, for the prevention of organ rejection in kidney, liver and heart transplants. Gengraf is a new cyclosporine capsule that is bioequivalent to, and interchangeable with, Neoral® capsules (cyclosporine capsules, USP [MODIFIED], Novartis), the leading cyclosporine capsule therapy. Additionally, Gengraf will be priced less than Neoral capsules.

``Gengraf is an important advance for transplant recipients due to the cost of medication that they must finance for the rest of their lives,'' said Lisa Kory, executive director, Transplant Recipients International Organization, Inc. (TRIO). ``Lower-cost, therapeutically equivalent medications are important options for transplant recipients.''

In addition, Gengraf has been granted an AB rating by the FDA. An AB rating designates that the product is therapeutically equivalent to, or interchangeable with, the reference drug. Under state pharmacy and Medicaid laws, an AB rating allows and, in some cases, mandates substitution of the lower-cost generic drug.

``The bioequivalence data support the interchangeability of Gengraf capsules and Neoral capsules,'' said Steve Tomlanovich, M.D., professor, Clinical Medicine and Surgery, University of California, San Francisco. ``Transplant recipients are hesitant to change therapy if it's working, therefore, convincing data are needed to assure recipients and transplant surgeons of the interchangeability of these drugs.''