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Alembic Pharmaceuticals receives USFDA nod for Lacosamide Tablets
Lacosamide Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, have an estimated market size of US dollar 1.67 billion for twelve months ending December 2021 according to IQVIA.
Vadodara: Alembic Pharmaceuticals Limited (Alembic) today 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.
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