Viatris Wins FDA Green Light for Generic Depot Drug; Weekly Contraceptive Patch Enters FDA Review Phase

Viatris made waves Thursday with a major regulatory haul spanning its entire pipeline—most notably securing FDA approval for its octreotide acetate injectable suspension, marking a significant milestone in the generic depot drug space. The approved formulation mirrors Sandostatin LAR Depot and provides long-acting symptom management for rare disorders like acromegaly, joining three other injectable approvals the agency has greenlighted so far this year.

The Generic Depot Drug Play: What It Means

The octreotide acetate approval represents the company’s fourth injectable win in 2025, clustering alongside iron sucrose, paclitaxel, and liposomal amphotericin B. For patients requiring depot drug therapy—long-acting formulations designed to minimize dosing frequency—this generic entry could reshape treatment accessibility and affordability in the rare disease segment.

Contraceptive Patch Clears FDA Desk; Decision Coming July 2026

In parallel, Viatris advanced its low-dose estrogen weekly transdermal contraceptive patch through FDA review gates. The patch combines 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol and targets women with BMI below 30 kg/m² seeking non-invasive, reversible birth control options. The FDA assigned a July 30, 2026 action date, setting the clock for approval decision.

Gene Therapy Momentum: MR-146 IND Cleared for Corneal Disease Trial

The company also secured investigational new drug clearance for MR-146, an AAV gene therapy candidate designed to combat neurotrophic keratopathy (NK)—a rare but vision-threatening corneal degeneration affecting roughly 73,000 Americans. Viatris plans to launch the Phase 1/2 CORVITA trial in H1 2026, testing whether gene therapy can halt or reverse the progressive corneal damage NK causes.

Japan Market Expansion: Pitolisant Advances in Sleep Disorders

Rounding out the regulatory sprint, Japan’s PMDA accepted Viatris’s drug application for pitolisant in obstructive sleep apnea syndrome (OSAS). The submission leans on Phase 3 data showing that patients receiving pitolisant scored significantly lower on the Epworth Sleepiness Scale compared to placebo (p=0.007) after 12 weeks—even among those whose daytime sleepiness persisted despite CPAP therapy. A separate narcolepsy application for Japan is targeted by year-end.

The flurry of regulatory momentum positions Viatris as a serious player across multiple therapeutic frontiers, from generic depot drug formulations to cutting-edge gene therapies and novel sleep disorder treatments.