OTC NARCAN Nasal Spray FDA approval with carrying case: Jan 9, 2026
Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
✓ APPROVED
OTC NARCAN Nasal Spray was approved by the FDA for emergency treatment of known or suspected opioid overdose (over-the-counter naloxone 4 mg nasal spray), packaged with a carrying case; the approval was announced on January 14, 2026.
The FDA approved a supplement for over-the-counter NARCAN Nasal Spray packaged with a carrying case on January 9, 2026 (NDA 208411, supplement 10). Emergent BioSolutions announced it on January 14, 2026.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (7/24/25) through T+5. Run-up high $13.9 on 1/7/26, low $5.63 on 8/1/25 (T-120 to T-1). Announced 1/14/26 (FDA action 1/9/26). Historical price action, not a forecast.
Positioning before the decision
On Dec 31, 2025, 14 days before the decision date, at-the-money options priced a move of ±10.1% through Jan 16, 2026 (the first listed expiry after the decision; ATM implied volatility 60%). The stock closed +3.0% at the first close across the decision and -5.5% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.
Key facts
FDA decision date2026-01-09
Announced2026-01-14
OutcomeApproved
Drug / candidateOTC NARCAN Nasal Spray - carrying case
IndicationEmergency treatment of known or suspected opioid overdose (over-the-counter naloxone 4 mg nasal spray), packaged with a carrying case
CompanyEmergent BioSolutions
Market-cap tierSmall
120-day run-up (T-120→T-1)+62.9%
Cohort decision-day move (history)3.7% median (n=302)
The FDA's approval letter for NDA 208411 supplement 10 is dated January 9, 2026 (FDA approval letter); Emergent announced the carrying case on January 14, 2026 (Emergent release). This is a packaging supplement, not a new indication. Correction, October 14, 2026: this page previously said the outcome was unverified; the FDA's letter dates the approval.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was OTC NARCAN Nasal Spray approved by the FDA?
Yes. The approval of the application for OTC NARCAN Nasal Spray was announced on January 14, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Which company is behind OTC NARCAN Nasal Spray?
OTC NARCAN Nasal Spray is an Emergent BioSolutions (EBS) program. The company announced the FDA decision on January 14, 2026; the company's own announcement is linked on this page.
How did EBS stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), EBS moved +62.9%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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