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U.S. Department of Health and Human Services

Animal & Veterinary

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Risk Minimization Action Plans (RiskMAPs) for Approved Products

 

  • 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:
     

PROHEART 6 (moxidectin) Sustained Release Injectable for Dogs (NADA 141-189)

RiskMAP
 

Recuvyra (fentanyl) Transdermal Solution (NADA 141-337)

In June 2012, FDA approved Recuvyra, a transdermal fentanyl solution used to control postoperative pain in dogs. Developed by Nexcyon Pharmaceuticals, Inc. under an agreement with Elanco Animal Health, Recuvyra is the first, and so far only, fentanyl product approved for animals.

Recuvyra is a potent opioid analgesic and its use is associated with serious safety concerns for both people and animals. Because of these concerns, Elanco launched Recuvyra under a Risk Minimization Action Plan (Risk MAP). The plan limits use of the drug to veterinarians who Elanco has certified as having completed specific training.

RiskMAP