Alembic Pharmaceuticals receives USFDA approval for Lacosamide Tablets

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) 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 product (RLD) Vimpat Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of UCB, Inc.

Lacosamide Tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

Lacosamide Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, have an estimated market size of US$ 1.67 billion for twelve months ending December 2021 according to IQVIA.

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