Last Updated on December 31, 2023 by The Health Master
Indoco Remedies Ltd. announced that the United States Food & Drug Administration (USFDA) 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, “Lacosamide injection of Indoco is the first generic version of Vimpat injection of UCB Inc., approved in the United States.
The ANDA approval and immediate launch of the product in the US market, echoes our commitment and consistent efforts to meet the unmet needs of the patients with quality and affordable healthcare.”
According to available IQVIA, sales data for Vimpat injection is approx. USD 43.8 million, growing at 25%.
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