Alembic Pharma receives US FDA final approval for Lacosamide tablets 

Alembic Pharma today announced that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lacosamide tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Vimpat Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of UCB, a statement from Alembic Pharma notified.

Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses, added the statement.