OTC NARCAN Nasal Spray FDA approval of 6-count and 24-count multipacks: Feb 11, 2026
Page updated ·next FDA decision on the calendar·Data as of Oct 15, 2026 10:03 PM ET
✓ APPROVED
OTC NARCAN Nasal Spray - 6-count and 24-count multipacks was approved by the FDA for emergency treatment of known or suspected opioid overdose (over-the-counter naloxone 4 mg nasal spray), new 6-count and 24-count packaging; the approval was announced on February 12, 2026.
The FDA approved a packaging supplement for over-the-counter NARCAN Nasal Spray adding 6-count and 24-count multipacks on February 11, 2026 (NDA 208411, supplement 11). Emergent BioSolutions announced it on February 12, 2026.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (8/21/25) through T+5. Run-up high $13.9 on 1/7/26, low $7.56 on 9/8/25 (T-120 to T-1). Announced 2/12/26 (FDA action 2/11/26). 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 date2026-02-11
Announced2026-02-12
OutcomeApproved
Drug / candidateOTC NARCAN Nasal Spray - 6-count and 24-count multipacks
IndicationEmergency treatment of known or suspected opioid overdose (over-the-counter naloxone 4 mg nasal spray), new 6-count and 24-count packaging
CompanyEmergent BioSolutions
Market-cap tierSmall
120-day run-up (T-120→T-1)+18.3%
Cohort decision-day move (history)3.6% median (n=281)
The FDA's approval letter for NDA 208411 supplement 11 is dated February 11, 2026 (FDA approval letter); Emergent announced the multipacks on February 12, 2026 (Emergent release). This is a packaging and labeling supplement, not a new indication. The separate carrying-case supplement (supplement 10) was approved January 9, 2026 and announced January 14, 2026. Correction, October 14, 2026: an earlier page on this site described a February 13 approval of the carrying case; the February action was the multipack supplement.
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 - 6-count and 24-count multipacks approved by the FDA?
Yes. The approval of the application for OTC NARCAN Nasal Spray - 6-count and 24-count multipacks was announced on February 12, 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 - 6-count and 24-count multipacks?
OTC NARCAN Nasal Spray - 6-count and 24-count multipacks is an Emergent BioSolutions (EBS) program. The company announced the FDA decision on February 12, 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 +18.3%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.