Alembic Pharmaceuticals receives USFDA approval for Lacosamide Tablets

25 Mar 2022 , 01:33 AM

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$ 167 billion for twelve months ending December 2021 according to IQVIA