Alembic Pharmaceuticals receives US FDA Tentative Approval for Dapagliflozin Tablets, 5 mg and 10 mg

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca). Dapagliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dapagliflozin Tablets have an estimated market size of US$ 1.7 billion for twelve months ending December 2018 according to IQVIA.

Alembic now have a total of 99 ANDA approvals (88 final approvals and 11 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.530 as compared to the previous close of Rs. 512.1. The total number of shares traded during the day was 4431 in over 453 trades.

The stock hit an intraday high of Rs. 536.15 and intraday low of 515. The net turnover during the day was Rs. 2351650.

Source : Equity Bulls

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