Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Lacosamide tablet, indicated for the treatment of partial-onset seizures in patients of 4 years of age and older.
The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Lacosamide Tablets of strengths 50 mg, 100 mg, 150mg, and 200 mg, the company said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product Vimpat Tablets -- 50 mg, 100 mg, 150 mg, and 200 mg -- of UCB Inc, it added.
"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," the company said.
Citing IQVIA data, the company said the Lacosamide tablets have an estimated market size of $1.67 billion for 12 months ending December 2021.
Alembic said it has received 23 approvals year to date, including 16 final approvals and 7 tentative approvals -- and a cumulative total of 161 ANDA approvals from USFDA.
