European Medicines Agency (EMA) has accepted the Trastuzumab application for review. In an interview to CNBC-TV18, Kiran Mazumdar Shaw, CMD of Biocon spoke at length about the same.
Mazumdar Shaw said that EMA communication with regards to Trastuzumab does not mean an approval.
She further said that we had to withdraw our file and now we have resubmitted, which means that they have not accepted it for a review.
Talking about US approval, she said target action date for US Food and Drug Administration (US FDA) nod for Trastuzumab is December 3.
According to her, there are no technical issues with application with EMA for Trastuzumab.
Watch accompanying video for more details.
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