CorMedix · DefenCath · 2021 – 2026
Why did the FDA call the name Defencath unacceptable in 2022?
The 2021 letter found it conditionally acceptable. The 2022 letter said it could be confused with another product under review, and that its acceptability depended on which was approved first. By 2026 DefenCath is the approved name.
EphemerisX Research · Published · 3 source documents · 1 min read
Short answer
The second letter says the name could be confused with another product also under FDA review, so its acceptability depended on which application was approved first. In 2021 the FDA had found it conditionally acceptable. CorMedix proposed an alternate name in March 2022; the 2025 10-K says DefenCath is the U.S. proprietary name the FDA approved. The other product is not identified in this record.
What the evidence shows
February 2021: the letter's opening refers to the product as Defencath (taurolidine 67.5 mg/5 mL (13.5 mg/mL) and heparin 5,000 USP Units/5 mL (1,000 Units/mL)) catheter lock solution
FDA · Feb 26, 2021 · p. 8, and the name was found conditionally acceptable pending approval of the application in the current review cycle
FDA · Feb 26, 2021 · p. 10.
August 2022: the opening refers only to taurolidine 67.5 mg/5 mL (13.5 mg/mL) and heparin 5,000 USP Units/5 mL (1,000 Units/mL) catheter lock solution
FDA · Aug 4, 2022 · p. 2. Under the heading for the proprietary name: This proposed name is unacceptable due to confusion with another product that is also under review
FDA · Aug 4, 2022 · p. 4. Therefore, the ultimate acceptability of your proposed proprietary name, Defencath, is dependent upon which application is approved first
FDA · Aug 4, 2022 · p. 4.
The letter notes that the company had proposed an alternate proprietary name in your submission dated March 3, 2022
FDA · Aug 4, 2022 · p. 4 (the alternate name is redacted), and that If Defencath is still your preferred proprietary name, you may indicate in the cover letter narrative that Defencath remains your preferred name
FDA · Aug 4, 2022 · p. 4.
The August 2022 press release does not mention the proprietary name or the letter's finding on it. 8-K · searched The release says There were no other deficiencies related to DefenCath cited in the CRL
8-K · Aug 9, 2022.
The 2025 10-K: The name DefenCath is the U.S. proprietary name approved by the U.S. Food and Drug Administration
10-K · Mar 5, 2026. Not in this record: which other product the FDA had in mind, or when the name was cleared.
Follow the thread
- What did the FDA's first letter on DefenCath require?2021: name “conditionally acceptable”
- What changed between the FDA's first and second letters on DefenCath?2022: name “unacceptable”
- How did CorMedix describe the FDA's second letter?The press release does not mention the name
This investigation connects to
- What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with Aldeyra Therapeutics, Outlook Therapeutics, Replimune, Verrica Pharmaceuticals
- What is a Class 1 or Class 2 resubmission, and how did each play out in these records?Cross-investigation · Regulatory pathway · with Aldeyra Therapeutics, Outlook Therapeutics, Replimune
- What happens when an FDA letter turns on a contract manufacturer, not the drug?Cross-investigation · Shared concern · with Verrica Pharmaceuticals
- What did “no efficacy or safety issues” cover in these FDA letter announcements?Cross-investigation · Shared concern · with Replimune, Verrica Pharmaceuticals
The documents, by date
The passages quoted
FDA Complete Response Letter, February 26, 2021 · page 8
Please refer to your new drug application (NDA) dated June 30, 2020, received June 30, 2020, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Defencath (taurolidine 67.5 mg/5 mL (13.5 mg/mL) and heparin 5,000 USP Units/5 mL (1,000 Units/mL)) catheter lock solution.Open at the source →
FDA Complete Response Letter, February 26, 2021 · page 10
Please refer to correspondence dated August 28, 2020, which addresses the proposed proprietary name, Defencath. This name was found conditionally acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiencies.Open at the source →
FDA Complete Response Letter, August 4, 2022 · page 2
Please refer to your new drug application (NDA) dated and received June 30, 2020, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for taurolidine 67.5 mg/5 mL (13.5 mg/mL) and heparin 5,000 USP Units/5 mL (1,000 Units/mL) catheter lock solution.Open at the source →
FDA Complete Response Letter, August 4, 2022 · page 4
We note that you proposed an alternate proprietary name in your submission dated March 3, 2022. In order to initiate the review of the alternate proprietary name, , submit a new request for proprietary name review when you respond to the application deficiencies. If Defencath is still your preferred proprietary name, you may indicate in the cover letter narrative that Defencath remains your preferred name.Open at the source →
FDA Complete Response Letter, August 4, 2022 · page 4
Please refer to correspondence dated July 20, 2022, which addresses the proposed proprietary name, Defencath. This proposed name is unacceptable due to confusion with another product that is also under review. Therefore, the ultimate acceptability of your proposed proprietary name, Defencath, is dependent upon which application is approved first.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
The August 2022 press release does not mention the proprietary name or the letter's finding on it.
Open the document →CorMedix Form 8-K, filed August 9, 2022
A second Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed to the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin during inspections are resolved to the satisfaction of FDA. There were no other deficiencies related to DefenCath cited in the CRL, and the Company expects that resolution of the site-specific compliance deficiencies will clear a pathway for FDA to approve the DefenCath NDA.Open at the source →
CorMedix Form 10-K, filed March 5, 2026
Our primary focus has been commercializing DefenCath® (taurolidine and heparin), in the U.S., which we launched in 2024 in the hemodialysis setting. The name DefenCath is the U.S. proprietary name approved by the U.S. Food and Drug AdministrationOpen at the source →