Indoco Remedies receives USFDA approval for Lacosamide Injection USP

Indoco Remedies Ltd. today 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 lndoco Remedies is bioequivalent and therapeutically equivalent tothe 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, Ms. Aditi Kare Panandikar, Managing Director - Indoco Remedies said, "Lacosamide Injection of lndoco 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 forVimpat® Injection is approx. USD 43.8 million, growing at 25%.

Shares of Indoco Remedies Limited was last trading in BSE at Rs. 392.80 as compared to the previous close of Rs. 390.05. The total number of shares traded during the day was 4299 in over 417 trades.

The stock hit an intraday high of Rs. 400.50 and intraday low of 388.25. The net turnover during the day was Rs. 1702225.00.

Source : Equity Bulls

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IndocoRemedies INE873D01024 USFDA Approval ANDA LacosamideInjection