USFDA gives approval for Brivaracetam Tablets

Brivaracetam Tablets is a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc.

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USFDA Approval
USFDA Approval

Last Updated on October 2, 2024 by The Health Master

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg,

Brivaracetam Tablets is a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc.

The product will be manufactured at Lupin’s facility in Nagpur, India.

Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, (RLD Briviact) had estimated annual sales of $420 million in the U.S. (IQVIA MAT September 2022).

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