Lupine Receives USFDA Approval for Meclizine Hydrochloride Tablets

Lupine today announced that it has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA), Meclizine Hydrochloride Tablets USP, 12.5 mg, 25 mg and 50 mg , to market a generic equivalent of Antivert Tablets, 12.5 mg, 25 mg and 50 mg, from Casper Pharma LLC.

The product will be manufactured at Lupin’s factory in Goa, India.

Meclizine hydrochloride tablets (RLD Antivert) had estimated annual sales of US$29 million in the United States (IQVIA MAT Jun 2022).

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)


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First published: Friday, August 12, 2022. 3:43 PM IST

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