The first drug approved by FDA of USA, that was produced through genetic engineering was
1. Somatotropin
2. insulin
3. penicillin
4. interferon

 Introduction: A Biotech Breakthrough

The first FDA-approved genetically engineered drug was human insulin, marking a monumental shift in medicine and biotechnology. Approved in 1982, this breakthrough laid the foundation for modern recombinant DNA technology in pharmaceuticals.

 Why Insulin Was Revolutionary

Before genetic engineering, insulin for diabetic patients was extracted from the pancreas of pigs or cows, which sometimes led to:

• Allergic reactions

• Limited supply

• Expensive production

With recombinant DNA technology, scientists inserted the human insulin gene into Escherichia coli (E. coli) bacteria, enabling large-scale, affordable, and human-compatible insulin production.

 FDA Approval of Recombinant Insulin

In 1982, the U.S. Food and Drug Administration (FDA) approved Humulin, the brand name for recombinant human insulin developed by Genentech and Eli Lilly. This approval made insulin the first genetically engineered product approved for human use.

 Why the Other Options Are Incorrect

1. Somatotropin (growth hormone) – Also produced via genetic engineering, but approved after insulin.

2. Penicillin – Discovered in 1928, produced naturally by fungi, not via genetic engineering initially.

3. Interferon – Important biotech product, but approved after insulin.

 Impact on Biotechnology and Medicine

The success of recombinant insulin:

• Opened doors for biopharmaceuticals (e.g., growth hormones, vaccines, monoclonal antibodies)

• Paved the way for gene therapy, biosimilars, and personalized medicine

 Conclusion

Insulin wasn’t just a lifesaver for millions with diabetes—it was a pioneer in the world of genetic engineering. As the first FDA-approved genetically engineered drug, it changed the course of medicine and kick-started the biotech revolution.