Lupin gets USFDA nod for generic drug

Lupin

Lupin on Friday said it has received the USFDA's approval to market its generic version of meclizine hydrochloride tablets indicated for prevention and treatment of nausea, vomiting, and dizziness caused by motion sickness.

The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of meclizine hydrochloride tablets of strengths 12.5 mg, 25 mg, and 50 mg, the pharmaceuticals company said in a regulatory filing.

These are the generic equivalent of Antivert tablets of Casper Pharma LLC. The product will be manufactured at Lupin's facility in Goa, it added.

Citing IQVIA MAT June 2022 data, the company said the Antivert meclizine hydrochloride tablets had an estimated annual sales of USD 29 million in the US.