Lacosamide Tablet by Glenmark Pharmaceuticals receives US approval

Glenmark stated that its present portfolio consists of 174 products authorised for distribution in the US market and 45 ANDAs (Abbreviated New Drug Applications) awaiting USFDA clearance.

Glenmark Pharmaceuticals Ltd announced on Monday that it had gained final approval from the US health regulator for the generic Lacosamide table, which is used to prevent and treat seizures.

In its statement, Glenmark Pharmaceuticals Inc, USA stated that the Lacosamide tablets of strengths 50 mg, 100 mg, 150 mg, and 200 mg had received approval from the US Food & Drug Administration (USFDA). 

These are generic versions of Vimpat pills of the corresponding strengths of UCB, Inc. The statement further added that the company intends to launch the product immediately. 

Robert Crockart, Chief Commercial Officer of Glenmark Pharmaceuticals Ltd, stated that the FDA approval for generic Lacosamide Tablets USP reiterates the ongoing commitment to making treatment options more accessible for patients. They are looking forward to quickly launching the product in the US market.

Vimpat tablets, 50 mg, 100 mg, 150 mg, and 200 mg market generated annual sales of approximately USD 1.7 billion, according to IQVIA sales statistics for the 12 months ending January 2022.

Glenmark stated that its present portfolio consists of 174 products authorised for distribution in the US market and 45 ANDAs (Abbreviated New Drug Applications) awaiting USFDA clearance.