Indoco Remedies secures final ANDA approval for Brivaracetam Oral Solution from USFDA
Brivaracetam Oral Solution will be manufactured by the company at its manufacturing facility located at Verna, Goa.
Indoco Remedies has secured final Abbreviated New Drug Application (ANDA) approval from United States Food and Drug Administration (USFDA) to market its ANDA for Brivaracetam Oral Solution, 10 mg/mL. 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 the company at its manufacturing facility located at Verna, Goa.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
