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AMRX FDA Decision Approved · 2025-11-13

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 11/13/25$11.95$7.165/29/25
Daily close, T-120 (5/29/25) through T+5. Run-up high $11.95 on 11/11/25, low $7.16 on 5/29/25 (T-120 to T-1). FDA decision 11/13/25. Historical price action, not a forecast.
Positioning before the decision
On Oct 30, 2025, 14 days before the decision date, at-the-money options priced a move of ±11.4% through Nov 21, 2025 (the first listed expiry after the decision; ATM implied volatility 58%). The stock closed -3.2% at the first close across the decision and -3.2% 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.

Decision facts

FDA decision date2025-11-13
DrugIohexol injection (300 mg Iodine/mL)
IndicationContrast agent
Outcome✓ Approvedprimary-sourced
Decision-day move-3.2%
T-120 run-up (low→high)+42.0% ($7.82→$11.95)
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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Questions

Was Iohexol injection (300 mg Iodine/mL) approved by the FDA?

Yes. The FDA approved the application for Iohexol injection (300 mg Iodine/mL) on November 13, 2025. The primary source is linked on this page.

What was Iohexol injection (300 mg Iodine/mL) under FDA review for?

The application covered Contrast agent. The FDA approved the application on November 13, 2025.

How did AMRX stock react to the FDA decision?

On the decision day AMRX moved -3.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.