Alembic Pharma has received final approval from the US health regulator for Lacosamide tablets, used for the treatment of partial-onset seizures, in the American market.
“The company has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg,” Alembic Pharmaceuticals said in a BSE filing.
The product is a generic version of drug firm UCB Inc’s Vimpat tablets in the same strengths, it added.
The launch of this product will be based on the outcome of the ongoing litigation in the US District Court with UCB, Alembic said.
The company was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, it added.
The tablets are indicated as adjunctive therapy in patients with the partial onset of seizures, Alembic Pharma said.
“The company currently has 47 ANDA approvals (43 final approvals and 4 tentative approvals from the USFDA,” it added.
Alembic stock was trading 0.17% down at Rs 601.90 in the afternoon trade on BSE.