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.
- Drug:
- CABTREO
- Announced Date:
- July 9, 2025
- Indication:
- For the Treatment of Acne Vulgaris
Announcement
Bausch Health, Canada Inc announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Ontario and Nova Scotia as well as through the federal government's Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations and that of the Correctional Service of Canada (CSC).
AI Summary
Bausch Health, Canada Inc. announced that its newly approved acne treatment, PrCABTREO™ (a gel combining clindamycin phosphate, adapalene, and benzoyl peroxide), is now available under public drug plans in Ontario and Nova Scotia. This innovative triple-combination topical treatment for acne vulgaris is approved for patients aged 12 and older and is the first of its kind authorized by Health Canada. The product is also accessible through the federal Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations and the Correctional Service of Canada (CSC) program.
This expanded access represents a significant step in ensuring that more Canadians benefit from advanced acne care. Bausch Health plans to complete listing arrangements with additional public drug plans across Canada, further broadening availability and providing new treatment options for those struggling with acne vulgaris.
Read Announcement- Drug:
- CABTREO
- Announced Date:
- November 18, 2024
- Indication:
- For the Treatment of Acne Vulgaris
Announcement
Bausch Health, Canada Inc., announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older,1 has received positive reimbursement recommendations from Canada's Drug Agency (CDA, formerly the Canadian Agency for Drugs and Technology in Health) and Quebec's Institut national d'excellence en santé et en services sociaux (INESSS).
AI Summary
Bausch Health, Canada Inc. announced that its new product, PrCABTREOTM gel, has received positive reimbursement recommendations from both Canada’s Drug Agency (formerly the Canadian Agency for Drugs and Technology in Health) and Quebec’s Institut national d'excellence en santé et en services sociaux (INESSS). PrCABTREOTM is a novel triple‐combination topical prescription treatment for acne vulgaris. It contains clindamycin phosphate, adapalene, and benzoyl peroxide in concentrations of 1.2% w/w, 0.15% w/w, and 3.1% w/w, respectively. The treatment is approved for patients aged 12 years and older.
The favorable reimbursement decisions by these reputable agencies indicate that the product is likely to be well received in the Canadian market. This recommendation is expected to improve access for patients and offers a promising new option for managing acne vulgaris effectively.
Read Announcement- Drug:
- CABTREO
- Announced Date:
- September 11, 2024
- Indication:
- For the Treatment of Acne Vulgaris
Announcement
Bausch Health, Canada Inc., announced the approval by Health Canada of PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older.1
AI Summary
Bausch Health, Canada Inc. announced that Health Canada has approved PrCABTREO™ (clindamycin phosphate, adapalene, and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% for treating acne vulgaris in patients 12 years and older. This new triple-combination treatment is unique as it combines an antibiotic, a retinoid, and an antibacterial agent, offering three mechanisms of action in one formulation.
The once-daily topical gel is designed to reduce both inflammatory and non-inflammatory acne lesions, providing a safe and effective option for millions of Canadians affected by acne. Experts note that its convenient application and robust clinical results could help improve the skin condition and overall quality of life for many people suffering from this common dermatological issue.
Read Announcement
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.
- Drug:
- PrCABTREOTM
- Announced Date:
- July 9, 2025
- Indication:
- For Treatment Of Acne Vulgaris
Announcement
Bausch Health, Canada Inc., part of Bausch Health Companies Inc. announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Ontario and Nova Scotia as well as through the federal government's Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations and that of the Correctional Service of Canada (CSC).
AI Summary
Bausch Health, Canada Inc., a part of Bausch Health Companies Inc., announced that its new acne treatment, PrCABTREOTM gel, is now accessible through several public drug plans. The product, which combines clindamycin phosphate, adapalene, and benzoyl peroxide, is approved for treating acne vulgaris in patients 12 years and older.
The gel is available to beneficiaries covered by the public drug plans in Ontario and Nova Scotia as well as through the federal government's Non-Insured Health Benefits program for Indigenous populations and the Correctional Service of Canada. This availability marks an important step in ensuring that more Canadians have access to effective acne treatment options. Bausch Health expressed optimism about future listing arrangements with other public drug plans nationwide, potentially extending access even further.
Read Announcement
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.
- Drug:
- XIFAXAN® (rifaximin)
- Announced Date:
- May 6, 2025
- 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.
Announcement
Bausch Health Companies Inc. announced new data showing that people hospitalized due to overt hepatic encephalopathy (OHE) had a reduced risk of OHE-related rehospitalization within 30 days if treated with Xifaxan® (rifaximin) following hospital discharge regardless of prior treatment.
AI Summary
Bausch Health Companies Inc. recently announced new data that shows patients hospitalized with overt hepatic encephalopathy (OHE) have a lower chance of being rehospitalized within 30 days when they receive Xifaxan® (rifaximin) at discharge. The analysis, which reviewed claims data from nearly 7,900 patients, found that the risk of rehospitalization was reduced for those treated with Xifaxan compared to patients who only received lactulose—regardless of whether they were on Xifaxan before their hospital stay.
This research supports current treatment guidelines that recommend Xifaxan as part of a comprehensive approach to managing OHE. By reducing the likelihood of rehospitalization, the findings underscore the importance of following guideline-based care to help patients with liver disease and ease the strain on the healthcare system.
Read Announcement- Drug:
- XIFAXAN® (rifaximin)
- Announced Date:
- January 17, 2025
- 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.
Announcement
Bausch Health Companies Inc acknowledged that the Centers for Medicare and Medicaid Services (CMS) has selected XIFAXAN® (rifaximin) 550 mg tablets as one of the medicines for the second round of negotiation as part of the Inflation Reduction Act with an initial price applicability in 2027 of the Drug Price Negotiation program.
AI Summary
Bausch Health Companies Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has selected its XIFAXAN® (rifaximin) 550 mg tablets for negotiation during the second round of the Drug Price Negotiation program, under the Inflation Reduction Act. This pricing initiative is expected to take effect in 2027. The company is preparing to engage in open discussions with CMS, aiming to share detailed information about the value that XIFAXAN provides to the healthcare system. Bausch Health also plans to present recommendations from respected liver organizations such as the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL), which have given XIFAXAN top ratings. This move is part of the company’s broader commitment to ensuring patient access to essential medications while promoting future healthcare innovation.
Read Announcement
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.
- Drug:
- XIPERE (triamcinolone acetonide injectable suspension)
- Announced Date:
- July 23, 2025
- Indication:
- Macular Edema Associated with Uveitis
Announcement
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).
AI Summary
Clearside Biomedical announced that Health Canada has approved XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use in treating uveitic macular edema (UME). This marks another milestone in the product’s global rollout, following earlier approvals in the United States, Australia, and Singapore, with regulatory review underway in China.
XIPERE is a specialized corticosteroid formulation designed to deliver medicine directly into the suprachoroidal space at the back of the eye. By targeting the affected area, the treatment aims to reduce swelling and improve vision in patients with UME. Bausch + Lomb holds the exclusive commercialization rights for XIPERE in the U.S. and Canada, while Arctic Vision manages licenses in Greater China, South Korea, Australia, New Zealand, India, and ASEAN countries.
Clearside’s suprachoroidal space (SCS®) injection platform uses a patented SCS Microinjector® to inject drugs with precision. This in-office, non-surgical approach may enhance effectiveness and limit side effects by keeping medication confined to the diseased tissue.
Read Announcement
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