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AMPH FDA decision: Feb 24, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

Ipratropium Bromide HFA Inhalation Aerosol was approved by the FDA; the approval was announced on February 24, 2026.

Amphastar Pharmaceuticals Inc., Ipratropium Bromide HFA Inhalation Aerosol.

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%

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was Ipratropium Bromide HFA Inhalation Aerosol approved by the FDA?

Yes. The approval of the application for Ipratropium Bromide HFA Inhalation Aerosol was announced on February 24, 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 Ipratropium Bromide HFA Inhalation Aerosol?

Ipratropium Bromide HFA Inhalation Aerosol is an Amphastar Pharmaceuticals Inc. (AMPH) program. The company announced the FDA decision on February 24, 2026; the primary source 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.