Alembic Pharmaceuticals Limited announces USFDA Final Approval for Dapagliflozin Tablets, 5 mg and 10 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final 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 product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca). Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: i) to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and ii) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Refer label for a detailed indication.

Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. Therefore, with this approval, Alembic is eligible for 180 days of shared generic drug exclusivity.

Dapagliflozin tablets, 5 mg and 10 mg, have an estimated market size of US$ 10,487 million for twelve months ending December 2025 according to IQVIA.

Alembic has a cumulative total of 235 ANDA approvals (217 final approvals and 18 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 690.25 as compared to the previous close of Rs. 656.15. The total number of shares traded during the day was 12143 in over 739 trades.

The stock hit an intraday high of Rs. 695.40 and intraday low of 653.00. The net turnover during the day was Rs. 8184871.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA DapagliflozinTablets