pdufa.bio
Home › Decisions › ANIP 2026-04-08

ANIP FDA decision: Apr 8, 2026

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

Isosorbide Mononitrate Tablet USP was approved by the FDA for angina attacks (chest pain); the approval was announced on April 8, 2026.

ANI Pharmaceuticals Inc., Isosorbide Mononitrate Tablet USP · Angina attacks (chest pain).

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

PDUFA 4/8/26$95.38$70.4910/22/25
Daily close, T-120 (10/22/25) through T+5. Run-up high $95.38 on 10/29/25, low $70.49 on 3/16/26 (T-120 to T-1). FDA decision 4/8/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-08
OutcomeApproved
Drug / candidateIsosorbide Mononitrate Tablet USP (generic o
CompanyANI Pharmaceuticals Inc.
120-day run-up (T-120→T-1)-10.4%

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