Lupin Limited on Friday 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.
According to the company’s statement, the approval will enable them to market a generic equivalent of Antivert Tablets, 12.5 mg, 25 mg, and 50 mg, of Casper Pharma LLC. Meanwhile, the product will be manufactured at Lupin’s facility in Goa, India.
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The company claims that Meclizine Hydrochloride Tablets (RLD Antivert) had estimated annual sales of USD 29 million in the U.S. (IQVIA MAT June 2022). According to the indications, this drug is prescribed for to prevent and control nausea, vomiting, and dizziness caused by motion sickness. It is also used for vertigo (dizziness or lightheadedness) caused by ear problems.
Lupin is a 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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.