Indoco Remedies Ltd. announced that the United States Food & Drug Administration (FDA) has approved the ANDA lacosamide injection USP, 200 mg/20 mL (10 mg/mL) single-dose vials. The generic lacosamide injection USP of Indoco Remedies is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vimpat injection of UCB, Inc.
Lacosamide injection is indicated for the prevention and control of seizures. It is an anticonvulsant/antiepileptic drug.
Commenting on the development, Aditi Kare Panandikar, managing director-Indoco Remedies said,
