MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol))

Dec. 18, 2025: Viatris Inc. (NASDAQ: VTRS) reported four regulatory milestones across its pipeline.

• Octreotide acetate for injectable suspension (generic Sandostatin LAR Depot): The U.S. FDA approved Viatris’ long-acting octreotide injectable. Indications include acromegaly (for patients who have responded to/tolerated subcutaneous Sandostatin Injection), severe diarrhea/flushing associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with vasoactive intestinal peptide–secreting tumors.

• Low dose estrogen weekly contraceptive patch (150 mcg norelgestromin / 17.5 mcg ethinyl estradiol): The FDA accepted Viatris’ 505(b)(2) NDA for review and assigned a PDUFA target action date of July 30, 2026. The filing is supported by Phase 3 Luminous Study results cited as showing favorable efficacy/safety and strong patch adhesion.

• MR-146 (ETF AAV gene therapy) for neurotrophic keratopathy: The FDA cleared the IND. Viatris plans to start the Phase 1/2 CORVITA trial in 1H 2026.

• Pitolisant in obstructive sleep apnea syndrome (Japan): Japan’s PMDA accepted the J-NDA, supported by positive Phase 3 data showing a statistically significant Epworth Sleepiness Scale improvement vs placebo at 12 weeks (p=0.007). Viatris also plans a J-NDA submission for narcolepsy by year-end.