Lupin gets USFDA approval for nasal spray; stock trades higher

4 Jul 2023 , 12:00 PM

Lupin’s stock rose more than 1% in early trade on July 4 after the company received approval from the US Food and Drug Administration (USFDA) for nasal spray.

At around 11.53 AM, Lupin was trading at Rs 895.60, up by 0.37%, against the previous close of Rs 892.30 on NSE. The counter rose to an intraday high of Rs 902.90.

The FDA has granted Lupin approval for its abbreviated new drug application for a nasal spray containing Cyanocobalamin at a strength of 500 mcg per spray. This nasal spray is a generic version of Par Pharmaceutical, Inc.’s Nascobal Nasal Spray, which also contains 500 mcg of Cyanocobalamin per spray.

Lupin said that it will manufacture the product at its Somerset facility in the US.

As per IQVIA MAT data of March 2023, Cyanocobalamin Nasal Spray had an estimated annual sale of USD 69 million in the United States.

Last month, the company announced the launch of Rufinamide Oral Suspension, 40 mg/mL, a generic equivalent of Eisai Inc.’s Banzel Oral Suspension, 40 mg/mL.

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