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.

Published On 2022-03-23 12:11 GMT   |   Update On 2022-03-23 12:11 GMT

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.

Read Also - Indoco Remedies launches Brinzolamide Ophthalmic Suspension 1% in US

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.

The facilities have been approved by most of the Regulatory Authorities including USFDA and UK-MHRA. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 70 million prescriptions annually from over 3,00,000 doctors belonging to various specialties. Indoco has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gyneacology etc.

Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, Cloben-G, Glychek, Kidodent, Carmicide, Rexidin, MCBM 69, Methycal, Homide, Cal-Aid, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.




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