Treats allergic reactions (Type I) including anaphylaxis. NDA 201739, held by Kaleo Inc. Epinephrine.
As of Nov 13, 2026, NDA 201739 (Auvi-Q), held by Kaleo Inc, was first approved by FDA on Aug 10, 2012, with 10 approved supplements and 0 published complete response letters.
AUVI-Q is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. AUVI-Q is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2017 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Aug 10, 2012 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Auvi-QEQ 0.3MG/DELIVERY · solution;intramuscular, subcutaneous | Epinephrine | RxReference drug |
| Auvi-QEQ 0.15MG/DELIVERY · solution;intramuscular, subcutaneous | Epinephrine | RxReference drug |
| Auvi-QEQ 0.1MG/DELIVERY · solution;intramuscular, subcutaneous | Epinephrine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2025 | Supplement 30Labeling · Standard review | Approved | |
| Feb 28, 2024 | Supplement 28Labeling · Standard review | Approved | |
| Sep 28, 2019 | Supplement 15Labeling · Standard review | Approved | |
| Nov 17, 2017 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 17, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Feb 17, 2017 | Supplement 6 | Approved | |
| Dec 19, 2016 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 18, 2016 | Supplement 4Labeling | Approved | |
| Apr 22, 2015 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 22, 2014 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 10, 2012 | Original applicationNew formulation or manufacturer · 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
