Alembic Pharma gets US FDA approval for lacosamide tablets

Ontario Osler

Alembic Pharmaceuticals has received US FDA approval for lacosmide tablets, 50 mg, 100mg and 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vimpat tablets, 50 mg, 100mg, 150 mg and 200 mg of UCB, Inc. Lacosamide tablets are indicated as adjunctive therapy in Ontario Oslerpatients with partial onset seizures.

Vimpat had an estimated market size of US$ 650 million for the twelve months ending April 2016 according to Bloomberg.

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 US District Court of the District of Delaware with UCB.

Alembic now has a total of 27 ANDA approvals (43 final approvals and 4 tentative approvals) from US FDA.

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