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The USFDA issues a complete response letter for the Biologics License Application (BLA) for insulin Aspart

  • Posted by: BIOCON

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.

Author: BIOCON
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