Core Insights - Viatris Inc. has announced four significant regulatory milestones in its global pipeline, highlighting advancements in research and development throughout 2025 [1][6][14] Group 1: Regulatory Approvals - The U.S. FDA has approved the company's octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot, for treating acromegaly and certain cancer-related symptoms [6][14] - This approval marks the fourth injectable FDA approval for Viatris in 2025, alongside iron sucrose, paclitaxel, and liposomal amphotericin B, showcasing the company's ability to navigate complex regulatory pathways [3][14] - The FDA has accepted the New Drug Application (NDA) for a low dose estrogen weekly patch for contraception, with a target action date of July 30, 2026 [6][14] Group 2: Pipeline Developments - The investigational low dose estrogen weekly patch is designed for women with a BMI below 30 kg/m², delivering approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol per day [4][7] - The planned 505(b)(2) NDA for the patch is supported by positive results from the Phase 3 Luminous Study, demonstrating a favorable efficacy and safety profile [5][14] - The U.S. FDA has cleared the Investigational New Drug (IND) application for MR-146, a gene therapy candidate for neurotrophic keratopathy, with plans to initiate a Phase 1/2 clinical trial in the first half of 2026 [6][9][14] Group 3: International Developments - The Japan Pharmaceuticals and Medical Devices Agency has accepted the Japanese New Drug Application (J-NDA) for pitolisant in obstructive sleep apnea syndrome, supported by positive Phase 3 data [6][11][14] - The Phase 3 trial for pitolisant showed statistically significant improvements in excessive daytime sleepiness compared to placebo, indicating its potential effectiveness [11][14]