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

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 - 403722 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."

Shares of Indoco Remedies Limited was last trading in BSE at Rs. 199.35 as compared to the previous close of Rs. 198.75. The total number of shares traded during the day was 731 in over 36 trades.

The stock hit an intraday high of Rs. 201.30 and intraday low of 198.00. The net turnover during the day was Rs. 145661.00.

Source : Equity Bulls

Keywords

IndocoRemedies INE873D01024 Pharmaceuticals FinalApproval ANDA USFDA BrivaracetamOralSolution