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Cumberland Pharmaceuticals (CPIX) FDA Events

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FDA Events for Cumberland Pharmaceuticals (CPIX)

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

Cumberland Pharmaceuticals' Drugs in FDA Review

ifetroban - FDA Regulatory Timeline and Events

ifetroban is a drug developed by Cumberland Pharmaceuticals for the following indication: In Duchenne Muscular Dystrophy Heart Disease. 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.

Vibativ - FDA Regulatory Timeline and Events

Vibativ is a drug developed by Cumberland Pharmaceuticals for the following indication: FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). 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.

Cumberland Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Cumberland Pharmaceuticals (CPIX) has reported FDA regulatory activity for the following drugs: ifetroban and Vibativ.

The most recent FDA-related event for Cumberland Pharmaceuticals occurred on June 23, 2025, involving ifetroban. The update was categorized as "Positive Results," with the company reporting: "Cumberland Pharmaceuticals shared the latest positive results from its Phase 2 FIGHT DMD trial evaluating ifetroban, a novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease, at the annual Parent Project Muscular Dystrophy (PPMD) conference in Las Vegas"

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

  • In Duchenne Muscular Dystrophy Heart Disease - ifetroban
  • FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) - Vibativ

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:CPIX) was last updated on 7/10/2025 by MarketBeat.com Staff
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