Lupine has received approval from the United States Food and Drug Administration (USFDA) for an abbreviated New Drug Application for cyanocobalamin nasal spray.
Lupine shares rose more than 1% in early trading on July 4 after the company received approval from the U.S. Food and Drug Administration (USFDA) for a nasal spray.
At 09:52 am, Lupine shares rose 0.7% to Rs898.35 on BSE. Shares are just 1 percent off their 52-week high of 908.4 rupees. The stock has risen nearly 40% over the past three months.
Lupine Receives Approval from the U.S. Food and Drug Administration (USFDA) for a Shortened New Drug Application for Cyanocobalamin Nasal Spray (500 μg/spray), the Generic Equivalent of Par Pharmaceuticals Nascobal Nasal Spray (500 μg/spray) bottom.
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This product is manufactured at Lupine’s facility in Somerset, USA.
According to IQVIA MAT data for March 2023, cyanocobalamin nasal spray is estimated to have annual US sales of $69 million.
Last month, the company launched Rufinamide Oral Suspension 40mg/mL, the generic equivalent of Eisai’s Banzel Oral Suspension 40mg/mL.
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