USFDA issues Complete Response Letter for Insulin Aspart application of Biocon

25 Oct 2022 , 12:06 PM

Biocon Limited has informed to the stock exchanges that, “The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Insulin Aspart filed by its partner Viatris (Mylan).

The CRL did not identify any outstanding scientific issues with the product. The CRL references the Form 483 observations noted during the pre-approval inspection of Biocon Biologics’ integrated insulins manufacturing facility at Malaysia in August 2022, which we disclosed on Aug 31, 2022.”

Further, in addition to this the company added, “We have submitted a CAPA (Corrective and Preventive Action) plan to the U.S. FDA for review and remain confident in our ability to resolve these observations expeditiously.

“Biocon Biologics remains committed to the global standards of Quality and Compliance.” – said Company Spokesperson.

At around 12:05 PM, Biocon Ltd is currently trading at Rs272.65 per share up by Rs2.45 or 0.91% from its previous closing of Rs270.20 per share on the BSE.

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