Alembic Pharma Receives USFDA Nod For Dabigatran Etexilate Capsules


Alembic Pharmaceuticals has received tentative approval from USFDA for its ANDA for Dabigatran Etexilate capsules, 150 mg.

Dabigatran Etexilate capsules are prescribed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parental anticoagulant for five to ten days.

It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.

Dabigatran Etexiulate capsules, 150 mg have an estimated market size of USD 726.3 million for 12 months ending December 2016.

Alembic has now a total of 60 ANDA approvals (52 approvals and 8 tentative approvals) from USFDA.  

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