Alembic says it received tentative USFDA nod for its anti-cardiac stroke medicine

Alembic Pharmaceuticals Limited on Friday announced it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its Dabigatran Etexilate capsules.

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 Ingelheim Pharmaceuticals.

Dabigatran drug is used to prevent stroke and atrial fibrillation which is a certain type of irregular heartbeat.  It also reduces the risk of harmful blood clots such as in legs (named as deep vein thrombosis) and lungs (named as pulmonary embolism).

This drug has an estimated market size of $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.

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