+91 80 2808 2808

USFDA issues a CRL for the Biologics License Application for Bevacizumab

  • Posted by: BIOCON


Bengaluru, Karnataka, India, Feb 12, 2023

“The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan). The CRL informs the need for a satisfactory resolution of the observations made during the facility inspection conducted in August, 2022. We have submitted a comprehensive Corrective and Preventive Action (CAPA) plan, to the agency and are confident of addressing the observations within the stipulated timeframe. The CRL did not identify any outstanding scientific issues with the dossier.”

– Company Spokesperson, Biocon Biologics.

Author: BIOCON
Leaving the Biocon site!

You are now leaving the Biocon website for a Biocon 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 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.

Agree >>