Indoco Remedies receives USFDA nod for Lacosamide Tablets
Lacosamide Tablets are indicated for the prevention and control of seizures. It is an anticonvulsant/antiepileptic drug.;
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Mumbai: Indoco Remedies Ltd. announces final approval from the United States Food & Drug Administration (USFDA) for Lacosamide Tablets USP 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets of UCB, Inc.
Lacosamide Tablets are indicated for the prevention and control of seizures. It is an anticonvulsant/antiepileptic drug.
Commenting on the development, Ms. Aditi Kare Panandikar, Managing Director-Indoco Remedies 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 US". According to IQVIA sales data for the period ending January 2022, Vimpat Tablets market achieved annual sales of approx. USD 1.7 billion.
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Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries. Indoco, a USD 166 million Company, employs over 6000 people including more than 300 skilled scientists. The Company has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APIs, supported by a state-of-theart R&D Centre and a CRO facility.
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