Vadodara-based drug maker Alembic Pharmaceuticals Ltd has informed that the company has received final approval from the US drug regulator - US Food and Drug Administration (USFDA) for its Lacosamide tablets, which is indicated as adjunctive therapy in patients with partial onset seizures.
A statement issued by the company mentioned that USFDA has approved the company's Abbreviated New Drug Application (ANDA) for Lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg.
"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vimpat tablets of UCB Inc," it said.
Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. The launch of this product will be based on the outcome of the ongoing litigation in the United States District Court for the District of Delaware with UCB.
Alembic now has 47 ANDA approvals (43 final approvals and 4 tentative approvals) from USFDA, the company informed.
Alembic Pharmaceuticals shares fell close to 1.5 per cent to Rs 593.55 on the National Stock Exchange (NSE) on Monday.