- When a drug has unusual risks but also has unusual benefits, the Sponsor may voluntarily implement a Risk Minimization Action Plan (RiskMAP).
- RiskMAPs use tools such as provider training and certification programs, informed owner consent, and enhanced Pharmacovigilance programs to achieve specific goals and objectives designed to minimize the risk while preserving the benefit of the drug. The Center for Drug Evaluation and Research published a guidance which describes how a RiskMAP has been utilized for human drugs.
- RiskMAPs have evaluation plans to periodically assess the effectiveness of the RiskMAP and whether it is achieving it goals.
- The RiskMAP documents for certain approved products are listed below:
RISK MINIMIZATION ACTION PLAN (RiskMAP) FOR:
PROHEART® 6 (moxidectin) for extended-release injectable suspension (NADA 141-189)
PROHEART® 12 (moxidectin) for extended-release injectable suspension (NADA 141-519)
Persons using assistive technology may not be able to fully access information in this RiskMAP. For assistance, please email AskCVM@fda.hhs.gov or call 240-402-7002.
- For more information about these products, visit our Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal Drugs page.