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Bausch Health Cos (BHC) FDA Approvals

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Bausch Health Cos' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Bausch Health Cos (BHC). Over the past two years, Bausch Health Cos has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CABTREO, PrCABTREOTM, XIFAXAN®, and XIPERE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

CABTREO FDA Regulatory Timeline and Events

CABTREO is a drug developed by Bausch Health Cos for the following indication: For the Treatment of Acne Vulgaris. 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.

PrCABTREOTM FDA Regulatory Events

PrCABTREOTM is a drug developed by Bausch Health Cos for the following indication: For Treatment Of Acne Vulgaris. 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.

XIFAXAN® (rifaximin) FDA Regulatory Events

XIFAXAN® (rifaximin) is a drug developed by Bausch Health Cos for the following indication: Indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. 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.

XIPERE (triamcinolone acetonide injectable suspension) FDA Regulatory Events

XIPERE (triamcinolone acetonide injectable suspension) is a drug developed by Bausch Health Cos for the following indication: Macular Edema Associated with Uveitis. 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.

Bausch Health Cos FDA Events - Frequently Asked Questions

In the past two years, Bausch Health Cos (BHC) 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, Bausch Health Cos (BHC) has reported FDA regulatory activity for the following drugs: CABTREO, XIFAXAN® (rifaximin), XIPERE (triamcinolone acetonide injectable suspension) and PrCABTREOTM.

The most recent FDA-related event for Bausch Health Cos occurred on July 23, 2025, involving XIPERE (triamcinolone acetonide injectable suspension). The update was categorized as "Provided Update," with the company reporting: "Clearside Biomedical, announced that Health Canada has granted approval for XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use in the treatment of uveitic macular edema (UME)."

Current therapies from Bausch Health Cos in review with the FDA target conditions such as:

  • For the Treatment of Acne Vulgaris - CABTREO
  • Indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. - XIFAXAN® (rifaximin)
  • Macular Edema Associated with Uveitis - XIPERE (triamcinolone acetonide injectable suspension)
  • For Treatment Of Acne Vulgaris - PrCABTREOTM

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 (NYSE:BHC) was last updated on 8/2/2025 by MarketBeat.com Staff
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