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Lupin Receives Approval from U.S. FDA for Meclizine Hydrochloride Tablets USP..

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Mumbai/Baltimore: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) 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, of Casper Pharma LLC. The product will be manufactured at Lupin’s facility in Goa, India.

Meclizine Hydrochloride Tablets (RLD Antivert®) had estimated annual sales of USD 29 million in the U.S. (IQVIA MAT June 2022).

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