FDA Logo links to FDA home page HHS Logo links to Department of Health and Human Services website U.S. Food and Drug Administration Center for Veterinary Medicine link to the Minor Uses and Minor Species page link to the Antimicrobial Resistance page link to the Biotechnology page link to the Aquaculture page link to the Food Safety page link to the BSE page link to the Guidance Documents page link to the Green Book page link to the Freedom of Information page
Center for Veterinary Medicine
Spacer Spacer


Powered by Google

" "

Table of Contents

Spacer Spacer
Minor Uses Minor Species (MUMS) Drug Designations

A sponsor can apply for Designation status for Minor Use and Minor Species drugs prior to their approval or conditional approval. If a drug is designated for MUMS purposes, the sponsor of the drug obtains seven (7) years of marketing exclusivity upon approval (or conditional approval) of the drug. Each designation that is granted must be unique, i.e., only one sponsor can be designated for a particular drug substance in a particular dosage form for a particular intended use.  The Center is following the final rule for designations to administer this provision. The final rule lays out how to apply for designation, what needs to be submitted and other information pertaining to this option.

MUMS Drug Designations List 

CVM Updates/FDA News

Federal Register Notices

  • Proposed Rule - Docket No. 2008N-0011, CVM 200775. Defining Small Number of Animals for Minor Use Designation. Pages 14411-14417 [FR Doc. E8-05385] March 18, 2008 [TXT] [PDF] [PRE-PUB] Comments due July 16, 2008

  • Final Rule - Docket No. 2005N-0329, CVM 200641. Designation of New Animal Drugs for Minor Uses or Minor Species. Pages 41010-41022 [FR Doc. E7-14444 ] July 26, 2007 [TXT] [PDF] [PRE-PUB] Effective date October 9, 2007

  • Proposed Rule - Docket No. 2005N-0329, CVM 200589. Designation of New Animal Drugs for Minor Uses or Minor Species; Reopening of the Comment Period. Page 76732 [FR Doc. 05-24512] [TXT] [PDF] [PRE-PUB] Comments due January 27, 2006

  • Proposed Rule - Docket No. 2005N-0329, CVM 20053. Designation of New Animal Drugs for Minor Uses or Minor Species. Pages 56394-56409 [FR Doc. 05-19196] September 27, 2005 | htm | | pdf | Comments on document by December 12, 2005 Comments on information collection due October 27, 2005

Web Page Updated by mdt - March 19, 2008, 1:05 PM ET

horizonal rule