Indoco Remedies gets USFDA’s approval for Lacosamide Injection

08 Apr 2022

Indoco Remedies has received an approval from the United States Food & Drug Administration (USFDA) for ANDA Lacosamide Injection USP, 200 mg/20 mL (10 mg/mL) single-dose vials. The generic Lacosamide Injection USP of the company 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. According to available IQVIA, sales data for Vimpat Injection is approximately $43.8 million, growing at 25%.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.