October 6, 2005
FDA Grants First Minor Use and Minor Species Drug Designations
FDA’s Center for Veterinary Medicine has granted the first minor use and minor species drug designations under the Minor Use and Minor Species Animal Health Act (MUMS.)
The designation of minor use and minor species drugs has been possible since the MUMS Act was signed into law in August of 2004. Designation is a package of incentives loosely modeled on those included in the Orphan Drug Act for human drugs. To be eligible for these, sponsors must apply for designation prior to filing a New Animal Drug Application for FDA approval. At the time that a designated drug gains approval or conditional approval, it is awarded 7 years exclusive marketing rights. This means that FDA will not approve another application for the same drug in the same dosage form for the same intended use until after the 7 years have elapsed. The proposed rule governing designation was published in the Federal Register on September 27, 2005.
The first drug to receive this designation is Florfenicol (Aquaflor®), and it has been designated for use in controlling conditions in four aquaculture species – catfish, hybrid striped bass, salmonids, and tilapia. Designations that are granted are posted on a list on the Minor Use and Minor Species page of the CVM website.
Any questions about MUMS designations may be directed to Dr. Andrew Beaulieu, Center for Veterinary Medicine (HFV-50), 7519 Standish Place, Rockville, MD 20855, 240-276-9090, e-mail Andrew.Beaulieu@fda.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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