Viatris Gets FDA Nod for Generic Sandostatin, Shares Regulatory Updates

Core Insights - Viatris Inc. (VTRS) has announced four significant regulatory achievements in its pipeline, highlighting its R&D progress for 2025 and its commitment to advancing its portfolio globally [2][9]. Regulatory Approvals - The FDA has approved Viatris' octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot, which is used for treating acromegaly and certain types of diarrhea related to tumors [3][4]. - This approval marks VTRS' first injectable product utilizing microsphere technology and is the fourth injectable approval for the company in 2025, enhancing its generics portfolio with complex, high-value products [4]. - The FDA has accepted VTRS' new drug application (NDA) for a low-dose estrogen weekly contraceptive patch, aimed at women with a BMI below 30 kg/m², with a target action date set for July 30, 2026 [5][6]. - The patch delivers approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol daily, representing a new option for women seeking lower estrogen doses [6][7]. - The FDA has cleared an investigational new drug (IND) application for MR-146, a gene therapy candidate for neurotrophic keratopathy, with a phase I/II clinical trial planned for the first half of 2026 [8][9]. - Viatris has also received acceptance for its Japanese NDA for pitolisant in obstructive sleep apnea syndrome (OSAS), with plans to submit a separate NDA for narcolepsy by year-end [10][11]. Company Performance - Viatris has demonstrated strong performance over the past six months, with shares increasing by 34.6%, compared to the industry growth of 6.1% during the same period [12]. - The company's expansion in Emerging Markets and robust growth in Greater China are positively impacting sales, with new drug approvals expected to further enhance its portfolio [13].