NOTIFICATION TO STOCK EXCHANGE
COMPANY STATEMENT
Bengaluru, Karnataka, India, Jan 07, 2022
“The U.S. FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Insulin Aspart filed by our partner Viatris (Mylan). We will respond to the CRL to satisfy the FDA’s requests. The CRL did not identify any outstanding scientific issues with the product.”
– Company Spokesperson, Biocon Biologics.
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