Alembic Pharmaceuticals gets USFDA Tentative Approval for Dabigatran Etexilate Capsules

Alembic Pharmaceuticals Limited today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa® Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer). Dabigatran Etexilate Capsules, are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients, treatment of deep venous thrombosis and pulmonary embolism in adult patients, reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients, prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg have an estimated market size of US$ 465 million for twelve months ending December 2021 according to IQVIA.

Alembic has received a cumulative total of 162 ANDA approvals (139 final approvals and 23 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 760.55 as compared to the previous close of Rs. 758.30. The total number of shares traded during the day was 5804 in over 467 trades.

The stock hit an intraday high of Rs. 764.80 and intraday low of 755.00. The net turnover during the day was Rs. 4415393.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 TentativeApproval USFDA ANDA DabigatranEtexilateCapsules