A complete response letter (CRL) was issued by the US Food and Drug Administration (US FDA) for the New Drug Application (NDA) for insulin glargine filed by partner Mylan, said Biocon.
In response to the observations made at the conclusion of the pre-approval inspection of the insulin manufacturing facility in Malaysia on June 2019, the CRL has been issued,
pending completion of the corrective and preventive actions (CAPAs) submitted to the US FDA, said the company in a statement.
The CRL did not identify any scientific issues with the application. During the commercial launch timing of our Insulin glargine in the US, this doesn’t anticipate any impact of this CRL and they remain confident of the quality of our application, adds the company.
“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 US FDA,” added Biocon.
The company said in a statement that the inspection was concluded with four observations which it believes will not impact supplies from this facility. They further added that they are confident of addressing these observations in a timely manner through a corrective and preventive action plan.