U.S. FDA Issues Complete Response Letter for New Drug Application for Insulin Glargine; Commercialization Plans Remain Unchanged

  • Posted by: Biocon Biologics


Company Statement

Bengaluru, Karnataka, India, Aug 31, 2019

“The U.S. FDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Insulin Glargine filed by our partner Mylan. The CRL has been issued pending completion of the Corrective And Preventive Actions (CAPAs) submitted to the U.S. FDA in response to the observations made at the conclusion of the pre-approval inspection of our insulin manufacturing facility in Malaysia in June 2019.

The CRL did not identify any outstanding scientific issues with the application. We remain confident of the quality of our application and do not anticipate any impact of this CRL on the commercial launch timing of our Insulin Glargine in the U.S.

We remain committed to global standards of Quality & Compliance and are working closely with our Partner and the regulator to complete these CAPAs to the satisfaction of the U.S. FDA.”

– Company Spokesperson

Author: Biocon Biologics