Aptar announced today that its Unidose liquid system received FDA approval to deliver ARS Pharmaceuticals’ neffy (epinephrine nasal spray). ARS won FDA approval last week for neffy as an emergency treatment for patients with Type I allergic reactions, including anaphylaxis. It marked a major innovation in epinephrine delivery as the first and only needle-free treatment […]
arspharmaceuticals
ARS Pharmaceuticals wins first FDA approval for needle-free, nasal epinephrine
ARS Pharmaceuticals (Nasdaq:SRPY) announced that it received FDA approval for its neffy (epinephrine nasal spray) 2 mg for treating of Type I allergic reactions. Approval includes the treatment of anaphylaxis, with the indication covering adults and children who weigh ≥30 kg (66 lbs.). It marks a major innovation in epinephrine delivery as the first and […]
FDA requests more info on neffy needle-free epinephrine
ARS Pharmaceuticals (Nasdaq:SRPY) says the FDA issued a complete response letter (CRL) regarding its neffy epinephrine nasal spray. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company initially set an anticipated target action date of mid-2023 for its PDUFA […]
FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals
ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription […]
ARS Pharmaceuticals wins fast track status for epinephrine nasal spray
ARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1. The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites. ARS Pharmaceuticals reported that the ARS-1 aqueous intranasal […]
