Indoco Remedies Gains USFDA Approval for Lacosamide Oral Solution
Filing Summary
Indoco Remedies Ltd. has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution USP, 10 mg/mL. This approval allows Indoco to market a generic equivalent to the reference listed drug, Vimpat Oral Solution, 10 mg/mL, by UCB, Inc. The product will be manufactured at Indoco’s facility in Verna, Goa. Lacosamide Oral Solution is used for treating partial onset seizures and primary generalized tonic-clonic seizures in patients aged four years and older.
Indoco Remedies Ltd. announced the final approval of its Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution USP, 10 mg/mL, from the USFDA. This approval permits the company to market a generic equivalent to the reference listed drug, Vimpat Oral Solution, 10 mg/mL, by UCB, Inc.
The Lacosamide Oral Solution will be manufactured at Indoco’s facility located in Verna Industrial Area, Goa. The product is indicated for the treatment of partial onset seizures and primary generalized tonic-clonic seizures in adults and children aged four years and older with epilepsy.
Indoco Remedies operates 11 manufacturing facilities, including seven for finished dosage forms and four for active pharmaceutical ingredients. These facilities are supported by a research and development center and a contract research organization facility. The company’s facilities have received approvals from various regulatory authorities, including the USFDA and UK-MHRA.
Indoco Remedies is a fully integrated, research-oriented pharmaceutical company with a significant global presence. The company develops and manufactures a wide range of pharmaceutical products for both Indian and international markets. Indoco generates over 106 million prescriptions annually from more than 240,000 doctors across various specialties.
Indoco Remedies has ten domestic marketing divisions and a strong brand portfolio in therapeutic segments such as Gastro-intestinal, Respiratory, Anti-Infectives, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, and Gynaecology. The company has established partnerships with large generic companies worldwide.