Alembic Pharmaceuticals Ltd has received final USFDA approval for its Lacosamide tablets, which is indicated as adjunctive therapy in patients with partial onset seizures. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vimpat tablets of UCB Inc. 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.
Company Profile : Alembic Pharmaceuticals Ltd
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