Epinephrine
FDA schedules Type A meeting to discuss epinephrine nasal spray
The FDA has scheduled a Type A meeting with ARS Pharma to discuss the complete response letter that the FDA previously issued to the company about its new drug application for its neffy epinephrine nasal spray.
Epinephrine nasal spray outcomes comparable with injected delivery
Pharmacokinetic and pharmacodynamic responses to a nasal epinephrine spray were comparable with responses to injected epinephrine, according to a study published in The Journal of Allergy and Clinical Immunology.
Top in allergy/asthma: FDA needs more data on nasal spray; what patients with asthma want
The FDA asked ARS Pharma for additional testing of its epinephrin nasal spray neffy, which was developed to treat type 1 allergic reactions, before the agency makes a decision regarding the company’s new drug application.
NY law requires educational materials about anaphylaxis, autoinjectors for teachers
New York Gov. Kathy Hochul has signed legislation that requires the state’s commissioner of health to provide written information on how to recognize anaphylaxis and use epinephrine autoinjectors to the state’s teachers.
FDA asks ARS Pharma for more testing in epinephrine nasal spray approval process
The FDA has issued a complete response letter to ARS Pharma concerning its new drug application for neffy epinephrine nasal spray, according to a press release from the company.
Top news of August: Patient-provider relationships, mold and mildew, schizophrenia, more
Healio compiled the most-read news in allergy, asthma and immunology posted in August.
Illinois enacts $60 price cap on epinephrine autoinjector two-packs
The price of a two-pack of epinephrine autoinjectors is set to be capped at $60 in Illinois following Gov. J.B. Pritzker’s signing of House Bill 3639 on Friday, Aug. 4.
New Jersey caps out-of-pocket inhaler, epinephrine autoinjector costs
Gov. Phil Murphy of New Jersey has signed legislation that will cap monthly out-of-pocket prescription costs for epinephrine autoinjectors at $25 and asthma inhalers at $50 in all state-regulated and public employee health insurance plans.
Top news of June: Peanut sensitization, wildfires, asthma and fast food, alpha-gal, more
Healio compiled the most-read news in allergy, asthma and immunology posted in June.
Top in allergy/asthma: Epinephrine spray action date; COVID-19 vaccine safety finding
The FDA has set a new target action date for ARS Pharmaceuticals’ neffy epinephrine nasal spray, which is designed to treat anaphylaxis and other type 1 allergic reactions without a needle or injection.