FDA Events for Wellgistics Health (WGRX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Wellgistics Health (WGRX).
Over the past two years, Wellgistics Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ROXYBOND. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ROXYBOND - FDA Regulatory Timeline and Events
ROXYBOND is a drug developed by Wellgistics Health for the following indication: abuse-deterrent immediate-release (IR) opioid pain medication.
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.
- Drug:
- ROXYBOND
- Announced Date:
- March 4, 2025
- Indication:
- abuse-deterrent immediate-release (IR) opioid pain medication
Announcement
Wellgistics Health, Inc announced that its wholly owned subsidiary, Wellgistics LLC, is collaborating with Protega Pharmaceuticals Inc. ("Protega"). Protega is the innovative specialty pharmaceutical company that launched ROXYBOND™ (oxycodone hydrochloride), the first and only FDA-approved abuse-deterrent immediate-release (IR) opioid pain medication in the U.S.
AI Summary
Wellgistics Health, Inc. announced a new partnership through its subsidiary, Wellgistics LLC, with Protega Pharmaceuticals Inc., an innovative specialty pharmaceutical company. Protega is known for launching ROXYBOND™, the only FDA-approved abuse‐deterrent immediate-release opioid pain medication available in the U.S. This collaboration will focus on increasing patient access to ROXYBOND™ for those who are appropriately prescribed the medication. It also aims to provide valuable education for independent pharmacists regarding abuse-deterrent pain management strategies and regulatory compliance. Wellgistics LLC, which distributes to over 5,400 independent pharmacies across all 50 states, will help improve access to these safer opioid options, especially in rural and underserved areas. Both companies hope by working together, they can support better-informed decisions in pain management and help ensure patients receive effective and responsible care.
Read Announcement
Wellgistics Health FDA Events - Frequently Asked Questions
As of now, Wellgistics Health (WGRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Wellgistics Health (WGRX) has reported FDA regulatory activity for ROXYBOND.
The most recent FDA-related event for Wellgistics Health occurred on March 4, 2025, involving ROXYBOND. The update was categorized as "Provided Update," with the company reporting: "Wellgistics Health, Inc announced that its wholly owned subsidiary, Wellgistics LLC, is collaborating with Protega Pharmaceuticals Inc. ("Protega"). Protega is the innovative specialty pharmaceutical company that launched ROXYBOND™ (oxycodone hydrochloride), the first and only FDA-approved abuse-deterrent immediate-release (IR) opioid pain medication in the U.S."
Currently, Wellgistics Health has one therapy (ROXYBOND) targeting the following condition: abuse-deterrent immediate-release (IR) opioid pain medication.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:WGRX) was last updated on 7/12/2025 by MarketBeat.com Staff
