Gengraf (cyclosporine capsules, USP, [modified]) by Abbott Laboratories has received approval from the U.S. Food and Drug Administration.
Gengraf is an immunosuppressant indicated for the prevention of organ rejection in patients who have received kidney, liver or heart transplants. Gengraf is bioequivalent to and interchangeable with the leading cyclosporine capsule therapy, according to a company news release, but is priced lower.
Gengraf capsules were reported easy to swallow by a panel of 101 healthy volunteers. In that study, 94 of 101 participants preferred the aroma of Gengraf capsules to that of another brand of cyclosporine capsules, according to the company.
Cyclosporine is the leading immunosuppressive drug used to prevent graft rejection in liver, heart and kidney transplant patients, the company says. The market for cyclosporine in the United States accounts for $480 million in annual sales.
The bioequivalence of Gengraf and the other leading cyclosporine capsules was demonstrated in two well-controlled, randomized pharmacokinetic studies, according to Abbott Laboratories.
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