Indoco Remedies gets final nod from US FDA for Lacosamide tablet

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.