NEW DELHI, Apr 7:
Alembic Pharmaceuticals Ltd on Thursday said it has received tentative approval from the US health regulator for its generic version of Dabigatran Etexilate capsules indicated for reduction of risk of stroke and prevention of blood clots.
The tentative approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Dabigatran Etexilate capsules of strengths 75 mg, 110 mg, and 150 mg, Alembic said in a statement.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug (RLD) product Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc (Boehringer), it added.
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, Alembic Pharmaceuticals said.
“It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses,” it added.
Citing IQVIA data, the company said Dabigatran Etexilate capsules, 75 mg, 110 mg, and 150 mg have an estimated market size of USD 465 million for 12 months ended December 2021.
The company said it has received a cumulative total of 162 ANDA approvals (139 final approvals and 23 tentative approvals) from USFDA. (PTI)
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