Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
Daily close, T-120 (6/17/25) through T+5. Run-up high $20.25 on 10/21/25, low $12.54 on 6/25/25 (T-120 to T-1). FDA decision 12/2/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 18, 2025, 14 days before the decision date, at-the-money options priced a move of ±23.2% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 99%). The stock closed -0.4% at the first close across the decision and -4.3% 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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Albuterol sulfate inhalation (PROAIR HFA generic) approved by the FDA?
Yes. The FDA approved the application for Albuterol sulfate inhalation (PROAIR HFA generic) on December 1, 2025, per the FDA's own record. The company announced it on December 2, 2025. The primary source is linked on this page.
What was Albuterol sulfate inhalation (PROAIR HFA generic) under FDA review for?
The application covered Bronchospasm related to exercise-induced or reversible obstructive airway disease. The FDA approved the application on December 2, 2025.
How did AMRN stock react to the FDA decision?
On the decision day AMRN moved -0.4%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.