- Glenmark received manufacturing and marketing approval from India’s drug regulator for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process.
- Phase 3 trial in India met the key endpoints and demonstrated reduction of viral load of 94% in 24 hours and 99% in 48 hours.
- NONS was safe and well tolerated in COVID-19 patients.
- Glenmark to market NONS under the brand name FabiSpray®
Glenmark Pharmaceuticals Limited and Canadian pharmaceutical company SaNOtize Research & Development Corp. today announced launch of its Nitric Oxide Nasal Spray under the brand name FabiSpray® in India; for the treatment of adult patients with COVID-19 who have high risk of progression of the disease. Glenmark earlier received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS as part of the accelerated approval process.
Commenting on the significance of this development, Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd. said, “As a leading pharmaceutical player, it is important that we are an integral part of India’s fight against the COVID-19 pandemic. We are happy to receive regulatory approval for Nitric Oxide Nasal Spray (FabiSpray®) and launch it in partnership with SaNOtize. This reaffirms our commitment of providing yet another safe and effective antiviral treatment for COVID-19, and we are confident it will offer patients a much needed and timely therapy option.”
