Biotechnology major Biocon on Saturday said the US health regulator has issued a Complete Response Letter for a new drug application for insulin glargine filed by the company's partner Mylan.
The United Food and Drug Administration (USFDA) has also issued four observations after cGMP inspection of one of Biocon's biologics drug product facilities in Bengaluru, the company said in a BSE filing.
"The USFDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) fur Insulin Glargine filed by our partner Mylan," it said.
As per the USFDA, a Complete Response Letter is sent to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form.
"The CRL has been issued pending completion of the corrective and preventive actions (CAPAs) submitted to the USFDA in response to the observations made at the conclusion of the pre-approval inspection of our insulin manufacturing facility in Malaysia in June 2019," a Biocon spokesperson said in a statement.
The CRL did not identify any outstanding scientific issues with the application, it added.
"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 US," the statement said.
Biocon is working closely with its partner and the regulator to complete these CAPAs to the satisfaction of the USFDA, it added.
The spokesperson also said the USFDA conducted a Current Good Manufacturing Practice (cGMP) inspection at one of the company's Biologics Drug Product facilities in Bengaluru from Aug 22 to 30, 2019.
"The inspection concluded with four observations which we believe will not impact supplies from this facility," the statement said.
Biocon is confident of addressing these observations through a corrective and preventive action plan in a timely manner, it added.
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