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.
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