<div id="readability-page-1">08:14 AM EST, 12/18/2025 (MT Newswires) -- Viatris ( VTRS ) said Thursday the US Food and Drug Administration approved octreotide acetate for injectable suspension, a generic version of Novartis' ( NVS ) Sandostatin LAR Depot, and cleared MR-146 for use in neurotrophic keratopathy clinical trials.Octreotide acetate for injectable suspension is approved for treatment in patients who have responded to and tolerated Sandostatin subcutaneous injection for acromegaly, severe diarrhea or flushing episodes associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with vasoactive intestinal peptide secreting tumors, the company said.Acromegaly is a disorder that causes abnormal growth of bones, organs, and tissues.With the approval of its investigational new drug application for MR-146, Viatris ( VTRS ) said it plans to initiate a phase 1/2 clinical trial in H1 2026 to evaluate the gene therapy candidate in people with neurotrophic keratopathy, a degenerative disease that causes progressive damage to the cornea and can be life-threatening.Additionally, the company said it also achieved regulatory milestones for its investigational low-dose estrogen patch in the US and pitolisant in Japan.The FDA has accepted for review the new drug application for the low dose estrogen weekly patch for contraception with a target action date of July 30, the company said.The company added that the Japan Pharmaceuticals and Medical Devices Agency has accepted the new drug application for pitolisant as a possible treatment for obstructive sleep apnea syndrome and that it remains on track to submit an application for narcolepsy before the end of 2025. MT Newswires does not provide investment advice. Unauthorized reproduction is strictly prohibited.</div>

晖致

Viatris 宣布获得 FDA 批准奥曲肽乙酸酯，这是 Sandostatin LAR Depot 的仿制药，用于治疗肢端肥大症和某些肿瘤。FDA 还批准了 MR-146 进行神经营养性角膜病的临床试验。Viatris 计划在 2026 年上半年进行 1/2 期试验。此外，Viatris 在美国和日本分别为低剂量雌激素贴片和匹托利桑达成了监管里程碑，相关的避孕和阻塞性睡眠呼吸暂停的申请正在审查中

晖致称 FDA 已批准奥曲肽乙酸盐，并允许 MR-146 进入临床试验阶段