Indoco Remedies has received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for brivaracetam oral solution, 10 mg/mL. The approval allows the company to market a generic equivalent of the reference listed drug (RLD), Briviact 10 mg/mL, developed by UCB, Inc.

The approved formulation has been determined to be bioequivalent and therapeutically equivalent to the branded product. Brivaracetam oral solution (10 mg/mL) is a prescription antiepileptic medicine indicated for the treatment of partial-onset seizures in patients aged one month and older.

The product will be manufactured at Indoco’s US FDA-approved facility located at L-14, Verna Industrial Area, Verna, Goa. 

Commenting on the development, Aditi Panandikar, Managing Director, Indoco Remedies, said the approval represents a significant milestone as the company continues to expand its portfolio in key global markets. She added that Indoco remains committed to delivering innovative and affordable healthcare solutions to patients worldwide.

Indoco Remedies operates 10 manufacturing facilities—six for finished dosage formulations and four for active pharmaceutical ingredients—supported by a state-of-the-art R&D centre and a contract research organisation (CRO) facility. Its facilities are approved by major regulatory authorities, including the US FDA and UK-MHRA.