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Oral insulin: Biocon seeks FDA nod

April 20, 2005 17:04 IST
Biotech major Biocon will file an application with the US Federal Drug Administration to begin clinical trials for oral insulin, which, it says, would be the world's first insulin that could be consumed orally.

Biocon has already done the pre-clinical animal toxicity studies of the oral insulin, for which it has tied up with US pharma start-up Nobex and will jointly file by December, the Integrated new drug application with the US FDA, Biocon chairman and managing director, Kiran Mazumdar Shaw said in Bangalore on Wednesday.

She said after filing the INDA with the US FDA, Biocon would begin human clinical trials of the product. Biocon already has a recombinant human insulin that is sold to diabetic patients in India.

"We are hoping that in three to four years time, we should start approaching market opportunities," she said about the oral insulin product.


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