FDA Approves Viatris Generic Version of Sandostatin LAR Depot

The FDA has approved Viatris' generic version of Sandostatin LAR Depot. The FDA also accepted Viatris' New Drug Application for a low dose estrogen weekly patch for contraception, with a target action date of July 30, 2026. Additionally, the FDA cleared the Investigational New Drug application for MR-146, an AAV gene therapy candidate for neurotrophic keratopathy, with a Phase 1/2 clinical trial planned for early 2026. In Japan, the Pharmaceuticals and Medical Devices Agency accepted Viatris' New Drug Application for pitolisant in obstructive sleep apnea syndrome.