Global pharma major Lupin Limited on Monday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Cyanocobalamin Nasal Spray, 500 mcg/spray (One Spray per Device).
According to the company’s press statement, it is a generic equivalent of Nascobal Nasal Spray, 500 mcg/spray of Par Pharmaceutical, Inc. This product will be manufactured at Lupin’s Somerset facility in the United States.
Cyanocobalamin is a form of vitamin B12 used to treat vitamin B12 deficiency.
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023).
