
USA FDA-Approved Epinephrine Delivery Systems
The U.S. FDA has approved several epinephrine auto-injector products for treatment of anaphylaxis:
- EpiPen® / EpiPen Jr. (Mylan / Viatris, manufactured by Pfizer)
- Generic epinephrine auto-injectors (made by Teva and others)
- Auvi-Q® (Kaléo, available in 0.1 mg, 0.15 mg, and 0.3 mg doses; includes voice instructions)
- Authorized generics of EpiPen and Adrenaclick
🔑 How to Be Sure
- Check FDA’s database: The FDA Orange Book lists approved epinephrine auto-injectors.
- Manufacturer verification: Only buy from reputable pharmacies or distributors. If a product doesn’t list “FDA-approved,” avoid it.
- Prescription requirement: In the U.S., all FDA-approved epinephrine devices require a prescription. If a site offers them OTC without prescription, that’s a red flag.
Bottom line:
In the U.S., the only FDA-approved epinephrine products are EpiPen, EpiPen Jr, Auvi-Q, Adrenaclick (and its authorized generic), Teva generics, and Symjepi.
Other products you see online (especially cheaper “anaphylaxis auto-injectors” without a brand) are usually not FDA-approved and should be avoided for safety and legal reasons.
How to Buy / Access
- Prescription Required: In the U.S., epinephrine auto-injectors require a prescription. (You can’t buy EpiPens OTC in the U.S.) Drugs.com
- Lower-cost Alternatives: The authorized generic for Adrenaclick is offered at CVS fo a lower cost for a two-pack cash price. CVS
- Online Telehealth + Pharmacy Services: Services like PlushCare allow you to consult a board-certified doctor and get a prescription. PlushCare
- Pharmacy Chains & Generics: Many pharmacies carry generics or authorized generics; checking with your local pharmacy often helps (and asking for generics may reduce cost).
Comparison Chart
Device | Available Doses / Strengths | Weight / Age Guidance | Features / Device Type | What to Watch / Key Differences |
---|---|---|---|---|
EpiPen® / EpiPen Jr. (and authorized generics, e.g. Teva) | 0.15 mg (“Jr”) and 0.3 mg (adult) FoodAllergy.org+2medicaid.nv.gov+2 | • 0.15 mg for children ~33-66 lb (≈ 15-30 kg) • 0.3 mg for ≥ 66 lb (≈ ≥ 30 kg) FoodAllergy.org+1 | Auto-injector; two-pack (you get 2 EpiPens or generics) FoodAllergy.org+1 | • Device design is familiar; many people trained on it • Requires holding in place ~3 seconds after injection • Generics look similar but may have minor differences (caps, labeling) Drugs.com+2FoodAllergy.org+2 |
Auvi-Q® | 0.1 mg, 0.15 mg, and 0.3 mg strengths Drugs.com+2U.S. Food and Drug Administration+2 | • 0.1 mg for children ~7.5-15 kg (≈ 16.5-33 lb) • 0.15 mg for ~15-30 kg (≈ 33-66 lb) • 0.3 mg for ≥ 30 kg (≈ ≥ 66 lb) U.S. Food and Drug Administration+2Drugs.com+2 | Auto-injector with voice-guided instructions; compact; includes a trainer version; device labeling changed in 2017 to shorter hold time (≈2 seconds) for all doses. U.S. Food and Drug Administration+1 | • Because of voice prompts, may be easier in emergencies for untrained user • Size / shape differs from pen-style; some people prefer the more “box-like” Auvi-Q for visibility/handling • Keep track of the dose color coding (to avoid mixups) • Be aware of recall history (though resolved) and always check current batch warnings U.S. Food and Drug Administration+1 |
Adrenaclick® (and its authorized generics) | 0.15 mg and 0.3 mg medicaid.nv.gov+1 | Same approximate weight cutoffs as EpiPen / Auvi-Q for dosing (0.15 mg for lower weight, 0.3 mg for heavier) medicaid.nv.gov+1 | Auto-injector; two cap design (one cap at each end) which is different from EpiPen or Auvi-Q; includes fixed-needle auto-injection mechanism. medicaid.nv.gov+2When Peanuts Attack+2 | Because of design differences (e.g. caps on both sides), important to train so you know how to use it correctly Needle cover after injection may be manual, so safety practices matter Some people find cap removal & handling more tricky in emergency situation Device size and handling may differ from pen-style ones When Peanuts Attack |
Nasal Delivery
Device | Available Doses / Strengths | Weight / Age Guidance | Features / Device Type | What to Watch / Key Differences |
---|---|---|---|---|
Neffy Nasal Spray Single-use nasal spray (epinephrine intranasal delivery) | 2.0 mg for ≥ 30 kg 1.0 mg for 15-30 kg | Approved for ages 4+ ≥ 15 kg (33 lbs) | Needle-free, single-dose Packaged in twos Works sitting/lying/standing Demo trainer available | Absorption may vary with nasal issues Second dose if needed after 5 min Emergency care always required Side effects: nasal irritation, jittery, ↑HR Some doctors recommend keeping auto-injector backup |