Indoco
Indoco Remedies Ltd stock jumps after major nod from US Food and Drug Administration—investors rush in
Mumbai/IBNS: The share prices of Indoco Remedies Ltd. on Tuesday climbed almost 7% after the company received the final Abbreviated New Drug Application (ANDA) from US Food and Drug Administration (USFDA) for Brivaracetam Oral Solution, 10 mg/mL, to market, CNBC TV 18 reported.
Brivaracetam Oral Solution is a generic equivalent to the reference listed drug (RLD), Briviact 10 mg/mL, of UCB, Inc.
The company said in a release that Brivaracetam Oral Solution, 10 mg/mL, has 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, 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.”
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