Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Hypertension: Developing Fixed-Combination Drug Products for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. The guidance focuses on development of two-drug combinations of previously approved drug products. This guidance incorporates the comments received for and finalizes the draft guidance for industry entitled “Hypertension: Developing Fixed-Dose Combination Drugs for Treatment” issued on January 26, 2018.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2Developing fixed-dose combination drugs for hypertension treatment
Two or more active ingredients combined at a fixed dosage
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Regulatory Activities
1Sponsors should conduct two randomized, double-blind, controlled trials.
Document Types
1Cybersecurity information should be included in device labeling
Attributes
1measured in millimeters of mercury (mmHg)
Technical Details
Substances
4drug product with distinct mechanism of action
drug product with distinct mechanism of action
drug product with distinct mechanism of action
drug product with distinct mechanism of action
Testing Methods
1using multiple doses of each component to show contribution; Comparing A plus B to A and to B at their highest approved doses
Clinical Concepts
6Significant effects are observed on both systolic and diastolic blood pressures
Significant effects are observed on both systolic and diastolic blood pressures
Showing that each component contributes to the blood pressure effect
Closely related population to heart failure
correlated with female sex in VAD study
comorbidity associated with obesity; Common weight-related comorbidity; Weight-related comorbidity
Standards & References
External Standards
1Sponsors should consult contemporary treatment guidelines
Related CFR Sections (1)
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry (Status: Final)
- Development of New Stereoisomeric Drugs (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation (Status: Draft)
- Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Status: Draft)
- Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (Status: Draft)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis (Status: Final)
- Codevelopment of Two or More New Investigational Drugs for Use in Combination (Status: Final)