Viatris receives FDA approval for generic Sandostatin plus 3 other milestones

Viatris Inc. (NASDAQ: VTRS) announced four regulatory developments across its pipeline, according to a company statement.

The U.S. Food and Drug Administration approved the company's octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot. The therapy treats patients with acromegaly, severe diarrhea and flushing episodes associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with Vasoactive Intestinal Peptide secreting tumors.

The FDA accepted Viatris' New Drug Application for a low dose estrogen weekly patch for contraception. The patch delivers 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day. The FDA assigned a target action date of July 30, 2026, under the 505(b)(2) regulatory pathway.

The FDA cleared the company's Investigational New Drug application for MR-146, a gene therapy candidate for neurotrophic keratopathy. Viatris plans to begin a Phase 1/2 clinical trial called CORVITA in the first half of 2026.

Japan's Pharmaceuticals and Medical Devices Agency accepted Viatris' Japanese New Drug Application for pitolisant in obstructive sleep apnea syndrome. The company said it remains on track to submit a Japanese application for narcolepsy by year-end.

The octreotide acetate approval represents Viatris' fourth injectable FDA approval in 2025, following iron sucrose, paclitaxel and liposomal amphotericin B. The octreotide product uses microsphere technology and marks the company's first approved injectable with this technology.

"These important milestones not only demonstrate the strength of our scientific and regulatory capabilities, but also our dedication to addressing areas of significant unmet medical need for patients," said Philippe Martin, Viatris Chief R&D Officer.

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