Indoco Remedies Ltd. has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL, marking another key milestone in its regulated markets portfolio.
The approval allows the company to market a generic version of Briviact 10 mg/mL, originally developed by UCB, Inc.. The product has been confirmed to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), ensuring the same safety, quality, and efficacy standards.
What Is Brivaracetam Oral Solution Used For?
Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (AED), also known as an anticonvulsant. It is used in the treatment of partial-onset seizures in patients aged one month and older. Partial-onset seizures, also referred to as focal seizures, begin in one area of the brain and are among the most common types of seizures.
The approval strengthens Indoco’s presence in the central nervous system (CNS) segment in the United States, a highly regulated and competitive pharmaceutical market.
Manufacturing Details
The approved product will be manufactured at Indoco Remedies’ state-of-the-art facility located at L-14, Verna Industrial Area, Verna, Goa, India. The facility complies with global regulatory standards, supporting the company’s expanding footprint in regulated markets such as the US.