# MR-107A-02 (fast-acting meloxicam) PDUFA Event: Moderate-to-severe acute pain

Canonical URL: https://biopharmsignal.com/pdufa-calendar/VTRS/mr-107a-02-acute-pain

Ticker: VTRS

Company: Viatris Inc.

Event date: 2026-12-27

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA (505(b)(2))

FDA decision expected. FDA assigned December 27, 2026 as the PDUFA goal date for the MR-107A-02 NDA.

## Event Timeline

### December 27, 2026 — FDA decision expected

FDA assigned December 27, 2026 as the PDUFA goal date for the MR-107A-02 NDA.

[Viatris — NDA acceptance and PDUFA date](https://newsroom.viatris.com/2026-05-18-U-S-FDA-Accepts-Viatris-New-Drug-Application-for-Fast-Acting-Meloxicam-for-the-Treatment-of-Moderate-to-Severe-Acute-Pain)

### May 18, 2026 — FDA accepted the NDA for review

FDA accepted the 505(b)(2) NDA for the fast-absorbing oral meloxicam formulation.

[Viatris — NDA acceptance](https://newsroom.viatris.com/2026-05-18-U-S-FDA-Accepts-Viatris-New-Drug-Application-for-Fast-Acting-Meloxicam-for-the-Treatment-of-Moderate-to-Severe-Acute-Pain)

### May 18, 2026 — Pivotal Phase 3 programme was summarized

Viatris reported positive results from two pivotal Phase 3 postoperative-pain studies, in bunionectomy and herniorrhaphy models.

[Viatris — Phase 3 programme summary](https://newsroom.viatris.com/2026-05-18-U-S-FDA-Accepts-Viatris-New-Drug-Application-for-Fast-Acting-Meloxicam-for-the-Treatment-of-Moderate-to-Severe-Acute-Pain)

## Related Pages

- VTRS PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/VTRS.md

- VTRS company profile: https://biopharmsignal.com/company/VTRS.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md