Viatris Achieves Milestone With FDA Approval of Generic Sandostatin LAR Depot Injection; Awaiting Regulatory Decision on Contraceptive Patch

Viatris Inc. (VTRS) unveiled significant regulatory progress across its global pharmaceutical pipeline, marking a series of approvals and clinical advancements in rare disease and contraceptive treatments.

FDA Greenlight for Long-Acting Generic Injectable

The pharmaceutical company secured FDA clearance for octreotide acetate injectable suspension, establishing itself as a generic alternative to the branded Sandostatin LAR Depot formulation. This long-acting injection addresses symptomatic management in rare disorders such as acromegaly. The approval represents Viatris’ fourth FDA-cleared injectable product this year, joining regulatory successes for iron sucrose, paclitaxel, and liposomal amphotericin B formulations.

Contraceptive Transdermal Patch Under FDA Review

Viatris’ New Drug Application for a low-dose estrogen transdermal patch containing 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol has moved forward in the FDA review process. The non-invasive weekly patch targets women of childbearing age with BMI below 30 kg/m² seeking reversible combined hormonal contraception. The regulatory agency assigned a targeted review completion date of July 30, 2026.

Gene Therapy Program Advances Into Human Trials

The investigational new drug clearance for MR-146, an Enriched Tear Film adeno-associated virus gene therapy, represents a breakthrough for neurotrophic keratopathy treatment. Approximately 73,000 Americans suffer from this rare, progressive corneal degenerative disease with potential sight-threatening consequences. Viatris plans to initiate the CORVITA Phase 1/2 clinical trial during the first half of 2026.

International Regulatory Expansion in Sleep Disorders

Japan’s PMDA accepted Viatris’ drug application for pitolisant targeting obstructive sleep apnea syndrome. The submission reflects positive Phase 3 clinical data demonstrating efficacy in Japanese patients experiencing excessive daytime sleepiness despite CPAP therapy. At week 12, pitolisant recipients showed statistically significant improvement on the Epworth Sleepiness Scale versus placebo (p=0.007). The company targets additional submission for narcolepsy indication by year-end.

VTRS shares traded at $11.66 in pre-market activity, reflecting a 0.34% decline on the Nasdaq.