Pharmaceuticals firm Indoco Remedies Ltd on Tuesday said it has received final approval
from the US health regulator for its generic Lacosamide tablet indicated for prevention and control of
seizures.
The approval granted by the US Food & Drug Administration (USFDA) for Lacosamide tablets is for strengths
of 50 mg, 100 mg, 150 mg and 200 mg. These are the generic version of Vimpat Tablets of UCB Inc, the company
said in a regulatory filing.
Indoco Remedies Managing Director Aditi Kare Panandikar said, "The ANDA approval for Lacosamide Tablets on
the day of patent expiry, reverberates our enduring commitment to make quality and affordable generic
medicines available to more patients in the United States. Our first shipment of Lacosamide tablets
has already reached the US". Lacosamide tablets are indicated for the prevention and control of seizures.
It is an anticonvulsant/antiepileptic drug, the company said.
Citing IQVIA sales data for the period ending January 2022, the company said the Vimpat tablets market
achieved annual sales of approximately USD 1.7 billion.
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)
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