Indoco Remedies Receives Final ANDA Approval from USFDA for Brivaracetam Oral Solution

Indoco Remedies Ltd. has announced the final approval of their Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL, by the US Food and Drug Administration (USFDA). This approval allows Indoco to market a generic equivalent to the reference listed drug (RLD), Briviact 10 mg/mL, of UCB, Inc. The oral solution has been determined to be bioequivalent and therapeutically equivalent to the RLD. The solution will be manufactured at Indoco's facility in Goa, India. This approval is a significant milestone for Indoco as it strengthens their presence in the regulated markets. Indoco Remedies is a fully integrated, research-oriented pharmaceutical company with a strong global presence and a wide range of products for the Indian and international markets.