Indoco Remedies has received final approval of its Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution USP, 10 mg/mL, to market, a generic equivalent to the reference listed drug (RLD), Vimpat Oral Solution, 10 mg/mL, of UCB, Inc. (UCB), from USFDA. Lacosamide Oral Solution USP, 10 mg/mL, is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat Oral Solution, 10 mg/mL, of UCB, Inc. (UCB).
Lacosamide Oral Solution USP, will be manufactured by Indoco Remedies, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa. Lacosamide Oral solution is used to treat partial onset seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy who are at least 4 years old.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
