Indoco Remedies receives USFDA approval for Lacosamide Oral Solution

Indoco Remedies announced final approval of the Company's 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 403722 in India.

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.

 

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