New Delhi, Jan 7 (PTI) Biocon Biologics, a subsidiary of biotechnology major Biocon, on Friday said the US health regulat💮or has not approved an application for Insulin Aspart filed by its partner Viatris Inc.
"The USFDA has issued a complete response letter (CRL) fo🌜r the biologics licence application (BLA) for Insulin Aspart filed by our partner Viatris (Mylan)," a Biocon Biologics spokesperson said in a regulatory filing.
The c🗹ompany will respond to the CRL to 🐼satisfy the FDA's requests, it added.
"The CRL did not identify any outstanding scientific issues with the✤ p🉐roduct," the spokesperson noted.
As per the USFDA, a CRL is sent to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form. PTI MSS HRS
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