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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You are now leaving the Biocon Biologics Corporate website for a Biocon Biologics U.S. Corporate microsite that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon Biologics affiliate sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.
You are now leaving the Biocon Biologics page for a Biocon Biologics affiliate site or third party site that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon Biologics affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.
