FDA Guidance for the Industry

General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products

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This guidance is intended to assist a potential applicant who plans to develop, and submit an abbreviated new drug application (ANDA) to seek approval of, a generic version of a solid oral opioid drug product that has the potential for abuse and which references an opioid drug product with abuse-deterrent properties described in its labeling.

The guidance recommends studies, including comparative in vitro studies, that should be conducted by the potential ANDA applicant and submitted to FDA in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug (RLD) with respect to all potential routes of abuse.

TABLE OF CONTENTS

I. INTRODUCTION

II. BACKGROUND

III. ABUSE DETERRENCE OF GENERIC SOLID ORAL OPIOID DRUG PRODUCTS

IV. GENERAL PRINCIPLES FOR EVALUATING THE ABUSE DETERRENCE OF GENERIC SOLID ORAL OPIOID DRUG PRODUCTS

V. ROUTES OF ABUSE

VI. COMPARATIVE IN VITRO STUDIES

VII. OTHER CONSIDERATIONS

  • A. Multiple Strengths
  • B. Pharmacokinetic Studies
  • C. Other Studies

VIII.DATA ANALYSIS

IX. ADDITIONAL STUDIES

  • Appendix 1: Mechanical Manipulation
  • Appendix 2: Abuse by Injection (parenteral route)
  • Appendix 3: Abuse by Ingestion (oral route)
  • Appendix 4: Abuse by Insufflation (nasal route)
    • Reduced Availability
    • Reduced Likability
  • Appendix 5: Abuse by Smoking (inhalation route)

Download FDA Guidance in PDF

Download “Generic Solid Oral Opioids” UCM492172.pdf – Downloaded 104 times – 2 MB

Last Updated: 2016-05-30

FDA Recommendations for Generic Solid Oral Opioids
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