VTRS · 8-K · 20260806PR000037
Product / Drug Pipeline Progress
Viatris Inc · 2026-08-06 · Importance 31 · Surprise 42 · In source text
The FDA approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system), a new combined hormonal contraceptive patch with low-dose estrogen. Viatris reported positive top-line Phase 3 results for VR-205, its targeted-release budesonide formulation Nefecon, in Japanese adults with primary immunoglobulin A nephropathy at risk of end-stage renal disease. The FDA accepted the New Drug Application for MR-107A-02, a fast-acting non-opioid meloxicam formulation for moderate-to-severe acute pain, with a PDUFA goal date of December 27, 2026. The company also received approval for generic ferric carboxymaltose injection in 750 mg/15 mL, 1000 mg/20 mL and 100 mg/2 mL strengths.
Key facts
- In July, FDA approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system), and the Company expects Gwyn Lo to be commercially available later this year source
- In June, FDA approved Viatris’s generic ferric carboxymaltose injection in three strengths: 750 mg/15 mL, 1000 mg/20 mL and 100 mg/2 mL source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | In July, FDA approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system), and the Company expects Gwyn Lo to be… |
| revenue | positive | probable | — | In June, FDA approved Viatris’s generic ferric carboxymaltose injection in three strengths: 750 mg/15 mL, 1000 mg/20 mL and 100 mg/2 mL |