Glenmark Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration has granted final authorization for its lacosamide tablets.
For those unaware, lacosamide tablets are a generic substitute for Vimpat tablets, which are used to treat partial-onset seizures in adults as well as children aged 1 month and above.
According to IQVIA’s sales data for the 12 months ending January 2022, the Vimpat Tablets market had annual sales of around USD 1.7 billion.
Glenmark Pharmaceuticals' Chief Commercial Officer, Robert Crockart, commented on the development, stating that the FDA authorization for lacosamide tablets USP reinforces the company’s ongoing promise to make more accessible treatment options for patients. The firm is excited to bring this product to the market in the United States as soon as possible.
For the unversed, Glenmark Pharmaceuticals is a global pharmaceutical company focused on innovation, with operations in Specialty, OTC, and Generics.
Glenmark Pharmaceuticals' current portfolio has a total of 174 products approved for distribution in the United States and 45 ANDAs (abbreviated new drug applications) awaiting FDA approval.
The company also stated that it is continuing to identify and analyze external development partnerships to replenish and stimulate the growth of its pipeline and portfolio.
It is worth mentioning here that the lacosamide tablets which are approved are USP, 50 mg, 150 mg, 100 mg, and 200 mg, which are generic versions of Vimpat tablets, 100 mg, 200mg, 50mg, and 150 mg. The product will be available immediately, according to the company's plans.
The drug company's consolidated net profit fell 3.4% to USD 31.4 million quarter on quarter, despite a 13.9% increase in net sales to USD 411.41 million. Glenmark Pharma shares were trading 0.82% higher on the BSE at around USD 5.86.
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