Alembic Pharma gets USFDA nod for Dabigatran Etexilate capsules

Alembic Pharma gets USFDA nod for Dabigatran Etexilate capsules

Daily Current Affairs   /   Alembic Pharma gets USFDA nod for Dabigatran Etexilate capsules

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Category : Science and Tech Published on: June 21 2024

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  • Alembic Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic Dabigatran Etexilate capsules in strengths of 75 mg and 150 mg. These capsules are indicated for reducing stroke and blood clot risks in adults with atrial fibrillation.
  • Additionally, the company has secured tentative approval from the USFDA for its generic Dabigatran Etexilate capsules in the 110 mg strength. This tentative approval is equivalent to the Reference Listed Drug, Pradaxa, marketed by Boehringer Ingelheim Pharmaceuticals.
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