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Viatris (VTRS) FDA Events

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FDA Events for Viatris (VTRS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Viatris (VTRS). Over the past two years, Viatris has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Cenerimod, EFFEXOR, meloxicam, and XULANE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Viatris' Drugs in FDA Review

Cenerimod - FDA Regulatory Timeline and Events

Cenerimod is a drug developed by Viatris for the following indication: In Lancet Rheumatology. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

EFFEXOR - FDA Regulatory Timeline and Events

EFFEXOR is a drug developed by Viatris for the following indication: In adults with generalized anxiety disorder (GAD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

meloxicam - FDA Regulatory Timeline and Events

meloxicam is a drug developed by Viatris for the following indication: For the Treatment of Moderate-to-Severe Acute Pain. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

XULANE LO - FDA Regulatory Timeline and Events

XULANE LO is a drug developed by Viatris for the following indication: For Birth Control in Women of Childbearing Potential. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Viatris FDA Events - Frequently Asked Questions

In the past two years, Viatris (VTRS) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Viatris (VTRS) has reported FDA regulatory activity for the following drugs: EFFEXOR, XULANE LO, meloxicam and Cenerimod.

The most recent FDA-related event for Viatris occurred on May 8, 2025, involving XULANE LO. The update was categorized as "Positive Results," with the company reporting: "Viatris Inc. announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of investigational XULANE LO low dose weekly dermal patch of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential."

Current therapies from Viatris in review with the FDA target conditions such as:

  • In adults with generalized anxiety disorder (GAD). - EFFEXOR
  • For Birth Control in Women of Childbearing Potential - XULANE LO
  • For the Treatment of Moderate-to-Severe Acute Pain - meloxicam
  • In Lancet Rheumatology - Cenerimod

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:VTRS) was last updated on 7/11/2025 by MarketBeat.com Staff
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