Glenmark Pharmaceuticals on March 21 said its subsidiary has received a final approval from the United States Food and Drug Administration (FDA) to produce Lacosamide tablets USP — 50, 100, 150 and 200 mg.
Lacosamide tablets USP is the generic version of Vimpat®2 tablets, 50, 100, 150 and 200 mg of UCB, Inc. According to IQVIATM data for the 12 month period ending January, Vimpat tablets clocked sales of around $1.7 billion.
The company in a filing with the BSE said it “plans to launch the product immediately”.
“The FDA approval for generic Lacosamide tablets USP reiterates our ongoing commitment to make treatment options more accessible for patients. We look forward to quickly launching this product in the US market,” Robert Crockart, chief commercial officer of Glenmark Pharmaceuticals, said.
Shares of Glenmark Pharmaceuticals gained more than 2 percent intraday on March 21 after this news broke. At 09:35 hours, Glenmark Pharmaceuticals was quoting at Rs 452.85, up Rs 8.95 or 2.02 percent on the BSE.
The firm has a presence across speciality, generics and over the counter businesses with 10 manufacturing facilities across four continents and operations in over 80 countries. Globally, it focuses on respiratory, dermatology and oncology as key therapy areas. Its portfolio consists of 174 products authorised for distribution in the US and 45 ANDAs (abbreviated new drug applications) pending approval.
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