Lupin receives USFDA approval for Meclizine Hydrochloride Tablets
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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First Published: Aug 12 2022 | 3:43 PM IST