Viatris Secures Four Global Regulatory Milestones With FDA Approval Of Octreotide, NDA Review For Estrogen Patch, IND Clearance For MR‑146 Gene Therapy, And PMDA Acceptance Of Pitolisant

• Receives U.S. Food and Drug Administration (FDA) Approval for Generic Version of Sandostatin® LAR Depot (Octreotide Acetate for Injectable Suspension)
• U.S. FDA Accepts New Drug Application for Low Dose Estrogen Weekly Patch for Contraception
• U.S. FDA Clears Investigational New Drug Application for MR-146 in Neurotrophic Keratopathy
• Japan Pharmaceuticals and Medical Devices Agency Accepts Japanese New Drug Application Filing for Pitolisant in Obstructive Sleep Apnea Syndrome

PITTSBURGH, Dec. 18, 2025 /PRNewswire/ -- Viatris Inc. (NASDAQ:VTRS), a global healthcare company, today announced four recent regulatory milestones spanning across all stages of its global pipeline:

• Octreotide Acetate for Injectable Suspension: The U.S. Food and Drug Administration (FDA) has approved the Company's octreotide acetate for injectable suspension, a generic version of Sandostatin® LAR Depot. The therapy is indicated for treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for acromegaly, severe diarrhea/flushing episodes associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with Vasoactive Intestinal Peptide secreting tumors.
• Low Dose Estrogen Weekly Patch: The U.S. FDA has accepted for review the New Drug Application (NDA) for the Company's investigational low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception. The NDA is accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a target action date (PDUFA) of July 30, 2026.
• MR-146: The U.S. FDA has cleared the Company's Investigational New Drug (IND) application for MR-146, an Enriched Tear FilmTM (ETF) Adeno-Associated Virus (AAV) gene therapy candidate targeted to treat people with neurotrophic keratopathy (NK). The Company plans to initiate a Phase 1 / 2 clinical trial, CORVITA, for MR-146 in patients with NK in the first half of 2026.
• Pitolisant: The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the Company's Japanese New Drug Application (J-NDA) for pitolisant in obstructive sleep apnea syndrome (OSAS). The Company remains on track to submit a J-NDA for narcolepsy by the end of the year.