From USFDA
Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration to manufacture and market Lascoamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg. Aurobindo was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, therefore, Aurobindo is eligible for 180 days of generic drug shared exclusivity. The launch of this product will be based on the outcome of the litigation in the United States Court with UCB.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Vimpat Tablets, 50mg, 100 mg, 150 mg and 200 mg of UCB, Inc.
Lascoamide Tablets is indicated for adjunctive therapy in the treatment of partial onset seizures.
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