Treats type I allergic reactions, including anaphylaxis. NDA 214697, held by Ars Pharms Operation. Epinephrine.
As of Nov 13, 2026, NDA 214697 (Neffy), held by Ars Pharms Operation, was first approved by FDA on Aug 9, 2024, with 4 approved supplements and 1 published complete response letter.
Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 15 kg or greater.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2026 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Mar 5, 2025 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Aug 9, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 19, 2023 | NDA 214697Clinical/Clinical Pharmacology, Product Quality, Device | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neffy2MG/SPRAY · spray;nasal | Epinephrine | RxReference drug |
| Neffy1MG/SPRAY · spray;nasal | Epinephrine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2026 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Mar 26, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Oct 24, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Mar 5, 2025 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Aug 9, 2024 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
