Description
Health Fraud products are articles of unproven effectiveness that are promoted to improve health, well being, or appearance. They can be drugs, devices, foods or cosmetics for human or animal use.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
10POTIGA (ezogabine) tablets
Dosage form for DRUG-X
dosage form of POTIGA
Antiepileptic Drugs category
Commonly studied using add-on or replacement designs
POTIGA is a potassium channel opener
A pure crystal modification of the compound of formula I characterized by tabular crystals and rapid solubility.
A pure crystal modification of the compound of formula I characterized by longish-tabular to columnar crystals.
A pure crystal modification of the compound of formula I characterized by specific X-ray reflections and IR bands.
Subject of DHCP letters
Stakeholders
10Addressee for the patent term extension application
FDA Contact for transfer of ownership
FDA Contact for email correspondence
VPNA representative communicating with FDA
FDA contact for T-Con regarding cardiac safety
VPNA representative contacting FDA
FDA contact for T-Con regarding dog study and white blood cell counts; FDA Contact for T-Con Request
Valeant representative for FDA communications
FDA contact for T-Con calls and emails
FDA Project Manager contact; FDA contact for emails and pre-NDA questions
Regulatory Context
Regulatory Activities
10Request submitted under 35 U.S.C. 156
Submission of a new supplement for labeling changes and REMS modification
Proposed modification to the Risk Evaluation and Mitigation Strategy
The venue where expert advice is provided to FDA; Proceedings involving review of product approval or safety; A meeting where experts review the safety and efficacy of a product.
Request for review of the name POTIGA
Meetings regarding any other aspect of drug development; General meeting regarding development and review of a product.; Type C meetings where the objective is to facilitate early consultation on the use of a biomarker.; FDA sends preliminary responses no later than 5 calendar days before the meeting date; Meeting type with 75 day scheduling goal
Safety reports submitted under an Investigational New Drug application.
Communication prior to New Drug Application submission
General Correspondence - Pre-NDA Mtg (Type B)
repeat-dose toxicity studies that support a carcinogenicity Special Protocol Assessment (SPA)
Document Types
10Patent document containing analytical data for substance modifications
Protocols submitted for PMR Reference Nos: 1781-2, 1781-3, 1781-4, and 1781-5
Time sensitive patent information submitted under sequence 0051
Adverse Drug Reaction report submission
dosage terminology on the container label and carton labeling should be consistent
statutory element of a REMS
Safety update sequence 0007
Letter confirming transfer of ownership
A document granting written permission to reference information from an NDIN Master File.
analytical testing site updated and new
Attributes
10Tablet strength
The required electronic format for DMF submissions.
CMC Information Amendment for 200 mg tablet
Fees required for the review of premarket submissions
Classification of Pre-NDA Meeting
Requirement for a separate IND for specific patient population
Property of retigabine free-base having multiple crystalline forms
Fee paid to USPTO to keep patent in force
Storage condition for POTIGA
threshold for dosage adjustment in renal impairment
Technical Details
Substances
10Active ingredient of POTIGA, also known as retigabine; Active ingredient in POTIGA; active ingredient in POTIGA used for partial-onset seizures; Active ingredient in Potiga tablets; USAN Adopted Name Change from Retigabine to Ezogabine; Established name for POTIGA; Active ingredient in POTIGA Tablets; Active ingredient in POTIGA tablets
Request for Change of Adopted Name to Lorvigabine
Earlier proposed proprietary name for retigabine
metabolite of retigabine studied in dogs
Referred to as NMDA Receptor Antagonist
The specific crystalline form used in clinical and formulation studies
Initial salt form of retigabine found to be unstable
The specific chemical form selected for development
Active drug substance discussed in development report; FDA Submission Log for Epilepsy; Subject of the FDA submission log; 13-Wk study of N-acetyl metabolite of retigabine in dogs; Active ingredient for epilepsy treatment; Active substance in POTIGA tablets; Alternative name for ezogabine used in early correspondence
NAMR, evaluated as an inhibitor of P-glycoprotein
Testing Methods
10Graph plotted against 2-Theta Scale indicating crystalline modifications; Method used to differentiate crystalline forms
New BE study results in a major amendment; Failure to demonstrate BE of the test product and reference standard
Clinical data required for safety evaluation; Safety assessment parameter (UA)
Pharmacology Toxicology study discussed in Info Amendment
Preclinical safety testing reported in IND Safety Report
Study 110-US discussed in T-Con
Analytical technique for identifying solid-state forms
Urodynamic measurement technique
EMG measurement in urodynamic trial
Urodynamic measurement technique
Processes
10example of a reprocessing step
Manufacturing process change for commercial image
Information Amendment regarding API and Finished Product; Chemistry, Manufacturing, and Controls information update
chemistry, manufacturing, and controls
Preclinical study in dogs reported to FDA
metabolic pathway for ezogabine involving NAT2
primary metabolic pathway for ezogabine
Alternative dosing strategy to improve tolerability.
Manufacturing processes for the novel modifications of the substance; Manufacturing methods described in the patent title; Manufacturing methods described in the patent title.
Method to obtain Modification B from Modification A at temperatures greater than 80°C.
Clinical Concepts
10Indication for POTIGA treatment; Indicated as adjunctive treatment of partial-onset seizures; indication for POTIGA treatment; Indication for Potiga as adjunctive treatment
Symptoms used for diagnostic and treatment order options
Expected toxicity with many MDS drugs
To assess for UTI, we recommend performing urinalysis
Request for info on cardiac events
Cardiac safety report for Protocol 103
Analysis of terms requested by FDA
Safety finding in case 2008VX000727
Subject of protocol amendment for study 303
FDA comments regarding cardiac safety
Identified Hazards
Hazards
2FDA concurrence on lack of RGB mutagenicity
Serious adverse event reported in safety reports
Standards & References
External Standards
3storage condition standard
The legal standard (BeurkG) cited for the notarization process.
Used to characterize Modification A of the compound
Specifications
4X-axis measurement for crystalline modification patterns
FDA email regarding drug substance stability
Y-axis measurement in W/g used to characterize thermal transitions
X-axis measurement in CM-1 for infrared absorption bands
Related CFR Sections (4)
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Recent Cases
- 2025-09-16
False & Misleading Claims/Misbranded
Novo Nordisk Inc.
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-06-10
False & Misleading Claims/Misbranded
Sprout Pharmaceuticals, Inc.
Related Warning Letters (7)
- 2025-09-16
False & Misleading Claims/Misbranded
Novo Nordisk Inc.
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-06-10
False & Misleading Claims/Misbranded
Sprout Pharmaceuticals, Inc.
- 2025-05-20
False & Misleading Claims/Misbranded
Sarfez Pharmaceuticals, Inc.
- 2021-02-23
False & Misleading Claims/Misbranded
CooperSurgical, Inc.
See Also (8)
- Accelerated Approval – Expedited Program for Serious Conditions (Status: Draft)
- Review of FDA's Implementation of the Drug Export Amendments of 1986 (Status: Final)
- E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Status: Final)
- Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (Status: Final)
- Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry (Status: Draft)
- Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory: Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities (Status: Final)
- E2BM Data Elements for Transmission Of Individual Case Safety Reports (Status: Final)
- Evaluating the Risks of Drug Exposure in Human Pregnancies (Status: Final)