pdufa.bio
HomeDecisionsAMPH 2026-02-24

AMPH FDA decision: Feb 24, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

Amphastar Pharmaceuticals Inc., Ipratropium Bromide HFA Inhalation Aerosol 1 · Bronchospasm associated with chronic obstructive p.

Run-up into the decision (T-120 → T+5)

PDUFA 2/24/26$30.81$23.149/9/25
Daily close, T-120 (9/9/25) through T+5. Run-up high $30.81 on 9/9/25, low $23.14 on 10/22/25 (T-120 to T-1). FDA decision 2/24/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-02-24
OutcomeApproved
Drug / candidateIpratropium Bromide HFA Inhalation Aerosol 1
CompanyAmphastar Pharmaceuticals Inc.
120-day run-up (T-120→T-1)-10.6%

Questions

Was Ipratropium Bromide HFA Inhalation Aerosol 1 approved by the FDA?

Yes. The FDA approved the application for Ipratropium Bromide HFA Inhalation Aerosol 1 on February 24, 2026. The primary source is linked on this page.

Which company is behind Ipratropium Bromide HFA Inhalation Aerosol 1?

Ipratropium Bromide HFA Inhalation Aerosol 1 is a Amphastar Pharmaceuticals Inc. (AMPH) program. The FDA decision came on February 24, 2026; the company's own announcement is linked on this page.

How did AMPH stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), AMPH moved -10.6%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.