When did the U.S. Food and Drug Administration approve recombinant insulin?

Created from Britannica articles using AI. AI can make mistakes, so verify using Britannica articles.

A step-by-step diagram shows donor DNA and vector DNA cut with restriction enzymes to create overhangs, mixed and sealed with ligase to form recombinant DNA, which is introduced into bacterial cells. The recombinant DNA replicates as the cells divide, producing clones. — biotechnology Steps involved in the engineering of a recombinant DNA molecule.

The U.S. Food and Drug Administration (FDA) granted approval for the marketing of recombinant human insulin, known as Humulin, in 1982.1

This milestone marked the first time a clinically significant, synthetic human protein was developed into a pharmaceutical product. The achievement was made possible through recombinant DNA technology, which allowed scientists to incorporate synthetic DNA sequences into Escherichia coli to direct the production of the hormone. This development by Genentech Inc. and Eli Lilly & Co. provided a vital alternative to the bovine and porcine insulin products that had been used to treat diabetes for decades.1