Lupin bags USFDA nod for Meclizine Hydrochloride Tablets
The product is a generic equivalent of Antivert Tablets, 12.5 mg, 25 mg, and 50 mg, of Casper Pharma LLC.
Mumbai: Global pharma major Lupin Limited has recently announced that the company 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.Meclizine Hydrochloride Tablets are indicated for the treatment and prevention of nausea, vomiting, and dizziness caused...
Mumbai: Global pharma major Lupin Limited has recently announced that the company 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.
Meclizine Hydrochloride Tablets are indicated for the treatment and prevention of nausea, vomiting, and dizziness caused by motion sickness.
The product is 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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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.
Read also: Lupin Diagnostics unveils Reference Laboratory in Ranchi
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