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US FDA tentative approval for Dapagliflozin - Zydus Cadila - Angel Broking

Posted On: 2020-10-30 08:29:19


Mr. Yash Gupta Equity Research Associate, Angel Broking Ltd

Zydus Cadila announced that the company has received tentative approval from the USFDA to market Dapagliflozin Tablets, 5 mg and 10 mg Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. Company believed that cadila is only company with tentative approval that has submitted a paragraph IV certification for US Patent No. 6,515,117 that claims the Dapagliflozin compound. The US District Court for the District of Delaware has scheduled a trial in February 2021 regarding Zydus Cadila's patent challenge. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad. This will be a very big opportunity for the company. Positive development for Zydus Cadila.

Shares of CADILA HEALTHCARE LTD. was last trading in BSE at Rs.417.7 as compared to the previous close of Rs. 411.2. The total number of shares traded during the day was 83357 in over 1767 trades.

The stock hit an intraday high of Rs. 419 and intraday low of 408.8. The net turnover during the day was Rs. 34620070.


Source: Equity Bulls

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