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Lupin receives USFDA’s approval for Meclizine Hydrochloride Tablets

12 Aug 2022 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) 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 $29 million in the U.S. (IQVIA MAT June 2022).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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