Indoco Remedies gets USFDA nod to sell generic epilepsy medicine
- IBEF
- February 2, 2026
The United States Food and Drug Administration (USFDA) has given Indoco Remedies Limited the final clearance for the company’s Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution, a generic version of the reference listed drug Vimpat Oral Solution manufactured by UCB. In addition, Indoco's product is a product with a reference strength of 10 mg/ml. Lacosamide is an important antiepileptic medication that is used to treat partial-onset seizure disorders as well as primary generalised tonic-clonic seizure disorders in children and adults over the age of four. “This regulatory achievement emphasises our continuing commitment to providing high-quality healthcare solutions on a global basis and reinforces our position in this regulated US market,” said the Managing Director of Indoco Remedies, Ms. Aditi Panandikar
The company will manufacture the approved product at its formulation facility in the Verna Industrial Area in Goa, India. Indoco operates a large amount of manufacturing capacity across 11 different sites that produce both finished pharmaceuticals and raw materials. Leveraging the opportunity to enter the US market for Lacosamide is important as Vimpat, its branded equivalent, has historically achieved more than Rs. 15,636.60 crore (US$ 1.7 billion) per year. Indoco expects that launching a bioequivalent generic version of Lacosamide will not only create a cost-effective option for patients but also stimulate revenue growth for Indoco's Mumbai-based business. Subsequently, Indoco's stock soared by 7% on the National Stock Exchange (NSE), showing that investors are optimistic about Indoco's growing US generic business.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
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