Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL

Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older

Indoco Remedies Ltd. announced final approval of the company’s Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL, to market, a generic equivalent to the reference listed drug (RLD), Briviact 10 mg/mL, of UCB, Inc.

Brivaracetam Oral Solution, 10 mg/mL, have been determined to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Briviact 10 mg/mL of UCB, Inc.

Brivaracetam Oral Solution, will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India.

Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older.

Commenting on the achievement, Ms. Aditi Panandikar, Managing Director said, “The ANDA approval for Brivaracetam is a significant milestone for us as we continue to strengthen our presence in the Regulated Markets. We are committed to offering innovative and affordable healthcare to patients worldwide.”