VTRS · 8-K · 20260806PR000037
Regulatory Approval Milestones
Viatris Inc · 2026-08-06 · Importance 31 · Surprise 42 · In source text
The U.S. FDA approved Gwyn Lo, a low-dose estrogen combined hormonal contraceptive patch, in July 2026, with commercial availability expected later in the year. In June, the FDA approved Viatris's generic ferric carboxymaltose injection in three strengths: 750 mg/15 mL, 1,000 mg/20 mL, and 100 mg/2 mL. The FDA also accepted the fast-acting meloxicam NDA for review and assigned a PDUFA goal date of December 27, 2026.
Key facts
- The FDA accepted for review the NDA for MR-107A-02 (fast-acting meloxicam) and assigned a PDUFA goal date of December 27, 2026 source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | unclear | contingent | — | The FDA accepted for review the NDA for MR-107A-02 (fast-acting meloxicam) and assigned a PDUFA goal date of December 27, 2026 |