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Viatris Inc. (VTRS) Gains FDA Approval for First Generic Iron Sucrose Injection

Company Overview - Viatris Inc. (NASDAQ:VTRS) was formed from the 2020 merger of Mylan and Pfizer's Upjohn division, delivering essential generic and specialty medicines to patients in over 165 countries [1] - The company maintains a broad portfolio across multiple therapeutic areas, focusing on sustainable growth, operational discipline, and shareholder returns [1] Recent Developments - In September 2025, Viatris achieved FDA approval for its first generic Iron Sucrose Injection, a complex generic version of Venofer, which is intended for iron deficiency anemia in chronic kidney disease patients [2] - The injection is available in three strengths, with two awarded Competitive Generic Therapy designation, granting 180 days of market exclusivity [2] - Venofer generates $515 million in annual U.S. sales, and this approval significantly strengthens Viatris' injectable portfolio [2] Financial Performance - Viatris reported strong Q2 2025 results, with revenues of $3.58 billion and adjusted EPS of $0.62, exceeding expectations while maintaining top-half guidance for the year [3] - The firm returned over $630 million to shareholders year-to-date, including $350 million in share buybacks [3] Research and Development - Pipeline progress includes positive outcomes from five Phase 3 studies, notably in ophthalmic solutions for night vision impairment and presbyopia, supporting upcoming FDA submissions [3] - Presentations at PAINWeek 2025 highlighted Viatris' R&D capabilities and commitment to clinical innovation in pain management [4] Leadership Changes - Andrew Enrietti was appointed Chief Administrative and Transformation Officer, and David Simmons joined the board to strengthen strategic oversight [4]