Friday, Oct 29, 1982

First Recombinant DNA Product Approved By The Food And Drug Administration

South San Francisco, Calif. -- October 29, 1982 --

Robert A. Swanson, president of Genentech, Inc. said today that approval by the Food and Drug Administration of human insulin produced by recombinant DNA technology, "is a tribute to the collaboration of two great scientific teams-- those at Eli Lilly and Genentech."

Humulin, the tradename of the new insulin, is being manufactured and marketed by Lilly under a license from Genentech. It is the first human health care product from recombinant DNA technology to reach the market.

U.S. government approval followed by only one month the recent approval by British regulatory authorities for introduction of the human insulin in the United Kingdom.

Swanson pointed out that approval by the Food and Drug Administration came only four years after scientists at Genentech and City of Hope National Medical Center, working together on the Genentech-funded project, successfully produced human insulin using recombinant DNA technology. "The FDA has quickly expanded the range of its expertise in the area of genetic engineering in order to be responsive to the rapid development of new products made possible by this new technology."

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