USFDA revises action date for Biocon’s Trastuzumab

DSIJ Intelligence / 31 Aug 2017

USFDA revises action date for Biocon’s Trastuzumab

As per a statement issued by Indian biopharmaceutical company Biocon, the USFDA has notified its partner Mylan that the regulator will extend the target action date for their Trastuzumab 351(k) application to December 3, 2017.

As per a statement issued by Indian biopharmaceutical company Biocon, the USFDA has notified its partner Mylan that the regulator will extend the target action date for their Trastuzumab 351(k) application to December 3, 2017.
 
The action was in order to review some of the clarifications submitted to them as a part of the application review process, the company said in a filing to the bourses on Wednesday after market hours.
 
The stock closed on a higher note by 0.78% at Rs 344 per share on the BSE. It opened at Rs 341.60 per share. On an YTD basis, the stock has advanced by around 8.19% till date. It attracted a total traded volume of 12,48,928 shares and traded value of Rs 4,310.92 lakhs on the NSE. The stock’s 52-week high was at Rs 438.85 per share as on July 19, 2017 and its 52-week low was at Rs 268.13 as on November 9, 2016. 
 
Biocon is a biopharmaceutical company. The company focuses on reducing therapy costs of chronic diseases like autoimmune, diabetes, and cancer. Through its products and research services it enables access to affordable healthcare for patients, partners, and healthcare systems across the globe.

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