Pharma major Lupin Ltd., on Monday said it has received approval from the U.S. health regulator for its generic version of Cyanocobalamin nasal spray.
The approval granted by the U.S. Food and Drug Administration is for the abbreviated new drug application for Cyanocobalamin nasal spray of strength 500 mcg/spray (one spray per device), Lupin said in a statement.
Cyanocobalamin nasal spray is used to maintain normal vitamin B12 blood levels in patients with pernicious anaemia.
"This product will be manufactured at Lupin's Somerset facility in the U.S.," the company added.
Cyanocobalamin nasal spray had estimated annual sales of $69 million in the U.S., Lupin said, citing IQVIA MAT March 2023 data.
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