Lacosamide pill shall be used for prevention and management of seizures. (Representational picture)
New Delhi:
Homegrown pharma main Glenmark Prescription drugs Ltd on Monday mentioned it has acquired last approval from the US well being regulator for its generic Lacosamide pill, indicated for prevention and management of seizures.
The approval granted by the US Meals & Drug Administration (USFDA) to the corporate’s arm Glenmark Prescription drugs Inc, USA, is for Lacosamide tablets of strengths 50 mg, 100 mg, 150 mg and 200 mg, Glenmark mentioned in a press release.
These are generic variations of Vimpat tablets of the corresponding strengths of UCB, Inc.
“The corporate plans to launch the product instantly,” it added.
Glenmark Prescription drugs Ltd Chief Business officer Robert Crockart mentioned, “the FDA approval for generic Lacosamide Tablets USP reiterates our ongoing dedication to make therapy choices extra accessible for sufferers. We stay up for rapidly launching this product within the US market.”
Citing IQVIA gross sales information for the 12 months ending January 2022, the corporate mentioned Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg market achieved annual gross sales of roughly USD 1.7 billion.
Glenmark mentioned its present portfolio consists of 174 merchandise authorised for distribution within the US market and 45 ANDAs (Abbreviated New Drug Functions) pending approval with the USFDA.