Indoco Remedies has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution, a generic equivalent of UCB Inc.’s Vimpat Oral Solution.

 

The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa. The medication treats partial onset seizures and primary generalized tonic-clonic seizures in adults and children aged four and above.

 

Commenting on the milestone, Aditi Panandikar, Managing Director, said, “We are excited about the ANDA approval for Lacosamide Oral Solution USP, 10 mg/ml. This approval further reinforces our commitment to delivering high-quality healthcare to patients worldwide.”