Indoco Remedies Receives USFDA Approval for Lacosamide Oral Solution ANDA
Mumbai: Indoco Remedies Ltd. has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution USP, 10 mg/mL, enabling the company to market a generic equivalent of Vimpat Oral Solution, 10 mg/mL, the reference listed drug (RLD) of UCB, Inc.
The company stated that Lacosamide Oral Solution USP, 10 mg/mL, is bioequivalent and therapeutically equivalent to the reference product. The approved product will be manufactured at Indoco Remedies’ formulation facility located at L-14, Verna Industrial Area, Verna, Goa – 403722, India.
Lacosamide Oral Solution is indicated for the treatment of partial-onset seizures and primary generalized tonic-clonic seizures in adults and paediatric patients aged four years and above suffering from epilepsy.
Commenting on the development, Aditi Panandikar, Managing Director, Indoco Remedies Ltd., said, “We are excited about the ANDA approval for Lacosamide Oral Solution USP, 10 mg/mL. This approval further reinforces our commitment to delivering high-quality healthcare to patients worldwide.”
The approval strengthens Indoco’s presence in the US generics market, particularly in the neurology segment, and follows recent regulatory progress for the company’s manufacturing facilities.
Indoco Remedies is a fully integrated, research-oriented pharmaceutical company with a global footprint. The company operates 11 manufacturing facilities, including seven finished dosage form units and four API plants, supported by a state-of-the-art R&D centre and a contract research organisation. Its facilities are approved by major global regulators, including the USFDA and UK-MHRA.
