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U.S. Food and Drug Administration
  1. Home
  2. Animal & Veterinary
  3. Development & Approval Process
  4. Minor Use/Minor Species
  5. Drug Designation
  1. Minor Use/Minor Species

Drug Designation

A sponsor can apply for Designation status for Minor Use and Minor Species (MUMS) drugs prior to their approval or conditional approval.  MUMS Designation is a status similar to “orphan drug” status for human drugs.  It makes the sponsor eligible for incentives to support the approval or conditional approval of the designated use.

DESIGNATION DOES NOT ALLOW THE DRUG TO BE MARKETED (SOLD, PROMOTED, OR ADVERTISED).  IT IS ILLEGAL TO MARKET THESE PRODUCTS UNTIL THEY ARE APPROVED OR CONDITIONALLY APPROVED.

When a drug is designated for a particular intended use, the sponsor of the drug obtains seven (7) years of exclusive marketing rights upon approval (or conditional approval) of the drug for that intended use. Each designation that is granted must be unique, i.e., only one designation can be granted for a particular drug substance in a particular dosage form for a particular intended use. The intended use includes both the target species and the disease or condition to be treated.

A sponsor of a designated new animal drug is also eligible to apply for grants to defray the cost of studies to support approval or conditional approval of the designated intended use.  The availability of these grants is announced periodically and a notice is posted to this website at that time.

Sponsors of designated new animal drugs are required to demonstrate “due diligence” toward approval or conditional approval through submission of annual reports documenting their progress for each designated use.

The Office of Minor Use and Minor Species Animal Drug Development (OMUMS) maintains a list of all designated new animal drugs and the intended uses for which they are designated on this website.

OMUMS is following the implementing regulations for designation to administer this provision of the statute. The regulations lay out how to apply for designation, what needs to be submitted and other information pertaining to this option.

Additional Information

 

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