CorMedix · DefenCath · Feb 2021
What did the FDA's first letter on DefenCath require?
Two product quality items: conditions found in records from Rovi's facility, and a fill-volume control the FDA said had not been shown to be appropriate. The letter's searchable text does not mention efficacy.
EphemerisX Research · Published · 1 source document · 1 min read
Short answer
The February 2021 letter named two product quality problems: objectionable conditions in records provided by Rovi Pharma Industrial Services' facility, and an in-process control on fill volume that had not been shown to be appropriate, with an extraction study requested. It also covered labeling, and found the name Defencath conditionally acceptable.
What the evidence shows
Under the heading for the facility, the letter says that in reviewing records provided by Rovi Pharma Industrial Services S.A. (FEI 3016688535) manufacturing facility, the FDA noted objectionable conditions
FDA · Feb 26, 2021 · p. 8. Those conditions will be conveyed to the representative of the facility within 10 business days of issuance of this Complete Response letter
FDA · Feb 26, 2021 · p. 8, and their resolution was required, (e.g., preapproval inspection and/or adequate facility responses addressing these conditions)
FDA · Feb 26, 2021 · p. 8.
The letter left open whether an inspection would be needed: If it is determined that an inspection is needed to approve your application
FDA · Feb 26, 2021 · p. 8, it said, the FDA continues to monitor the public health situation as well as travel restrictions
FDA · Feb 26, 2021 · p. 8.
The second item concerned the manufacturing process: You have not demonstrated that the currently proposed in-process control
FDA · Feb 26, 2021 · p. 9 (part of the sentence is redacted) is appropriate
FDA · Feb 26, 2021 · p. 9. The letter adds: As previously communicated to you, conduct and provide results of an extraction study to demonstrate that the labeled volume of the drug product solution (5 mL) can be consistently withdrawn from vials
FDA · Feb 26, 2021 · p. 9.
On the name, the letter says Defencath was found conditionally acceptable pending approval of the application in the current review cycle
FDA · Feb 26, 2021 · p. 10. That finding changed in the second letter: Why did the FDA call the name Defencath unacceptable in 2022?
The searchable text of the two letters (one PDF) does not mention efficacy, effectiveness or the LOCK-IT-100 trial. One page of the February 2021 letter has no text layer and could not be searched. FDA · searched CorMedix's account of the letter addressed that point directly: How did CorMedix describe the FDA's first letter?
Follow the thread
- How did CorMedix describe the FDA's first letter?“As previously communicated”: the extraction study
- What changed between the FDA's first and second letters on DefenCath?Rovi's records, 2021
- Which manufacturer was DefenCath approved with, and what happened to the alternatives?Rovi: named in 2021, approved with in 2023
- Why did the FDA call the name Defencath unacceptable in 2022?2021: name “conditionally acceptable”
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 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
During a review of records requested under Federal Food, Drug, and Cosmetic Act section 704(a)(4), provided by Rovi Pharma Industrial Services S.A. (FEI 3016688535) manufacturing facility, the FDA noted objectionable conditions. These objectionable conditions will be conveyed to the representative of the facility within 10 business days of issuance of this Complete Response letter. Satisfactory resolution of these objectionable conditions is required (e.g., preapproval inspection and/or adequate facility responses addressing these conditions) before this application may be approved.Open at the source →
FDA Complete Response Letter, February 26, 2021 · page 8
If it is determined that an inspection is needed to approve your application, please note that FDA continues to monitor the public health situation as well as travel restrictions. We are actively working to define an approach for scheduling outstanding inspections, once safe travel may resume and based on public health need and other factors.Open at the source →
FDA Complete Response Letter, February 26, 2021 · page 9
You have not demonstrated that the currently proposed in-process control for the ( mL± mL) in the drug product manufacturing process is appropriate. As previously communicated to you, conduct and provide results of an extraction study to demonstrate that the labeled volume of the drug product solution (5 mL) can be consistently withdrawn from vials, including vials that are . Revise the based on the results of the extraction study conducted.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
The searchable text of the two letters (one PDF) does not mention efficacy, effectiveness or the LOCK-IT-100 trial. One page of the February 2021 letter has no text layer and could not be searched.
Open the document →