Indoco Remedies Bags USFDA Nod For Lacosamide Injection

Published On 08 April 2022 03:30 PM | Updated On 08 April 2022 03:11 PM

Mumbai, April 8, 2022: Indoco Remedies Ltd. today announced that the United States Food & Drug Administration (USFDA) has approved the ANDA Lacosamide Injection USP, 200 mg/20 mL (10 mg/mL) single-dose vials.

The generic Lacosamide Injection USP of Indoco Remedies is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vimpat®? Injection of UCB, Inc.

Lacosamide injection is 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, “Lacosamide Injection of Indoco is the first generic version of Vimpat® Injection of UCB Inc., approved in the United States. The ANDA approval and immediate launch of the product in the US market, echoes our commitment and consistent efforts to meet the unmet needs of the patients with quality and affordable healthcare.

According to available IQVIA, sales data for Vimpat® Injection is approx. USD 43.8 million, growing at 25%.

Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries.The Company has 9 manufacturing facilities, 6 for FDFs and 3 for APIs, supported by a state-of-the-art 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.