December 13, 2007

MAJOR AQUACULTURE DRUG APPROVAL FOR AQUAFLOR®

FLORFENICOL (AQUAFLOR®) WAS APPROVED IN THE UNITED STATES FOR CONTROL OF MORTALITY IN FRESHWATER-REARED SALMONIDS DUE TO FURUNCULOSIS ASSOCIATED WITH AEROMONAS SALMONICIDA (OCTOBER 26, 2007)

The sponsor, Schering-Plough Animal Health Corporation (SPAH, Union, New Jersey; www.schering-plough.com), is to be again congratulated for this success and for investing in this approval. This is a very important approval because it is:

The first antimicrobial approved for controlling mortality due to furunculosis outbreaks in 20 years
The third label claim approved for Aquaflor®, the first new antimicrobial approved for aquatic species in more than two decades
The third label claim for Aquaflor® to gain designation under the Minor Use and Minor Species Animal Health Act which entitles SPAH to seven years of exclusivity for marketing rights
The third label claim approval for Aquaflor®, a drug that is classified as a Veterinary Feed Directive drug
This approval will greatly benefit the commercial salmonid industry and public production of any salmonid reared in fresh water. Furunculosis is a serious pathogen that causes significant losses of hatchery-reared salmonids, including losses at state and federal hatcheries producing fish for native salmonid restoration programs.

The approval of Aquaflor® for controlling mortality due to furunculosis in freshwater-reared salmonids is the result of a cooperative effort among the sponsor, Schering-Plough Animal Health Corporation (SPAH, Union, New Jersey), federal researchers, and the National Coordinator for Aquaculture New Animal Drug Applications. Aquatic Animal Drug Approval Partnership Program (AADAP, U.S. Fish and Wildlife Service, Bozeman, Montana) conducted and coordinated the pivotal and supportive efficacy studies. The U.S. Fish and Wildlife Service’s Makah National Fish Hatchery aided AADAP in conducting the effectiveness studies. The Upper Midwest Environmental Sciences Center (UMESC, U.S. Geological Survey, La Crosse, Wisconsin) supported the effectiveness studies by providing feed analyses. SPAH used the UMESC effluent survey to support the environmental assessment for continuous-flow systems. AADAP and UMESC developed the data with financial support through base funds and the Federal-State Aquaculture Drug Approval Partnership Project that was under the auspices of the Association of Fish and Wildlife Agencies. The National Coordinator for Aquaculture New Animal Drug Applications provided coordination of the research efforts with all involved partners including the Center for Veterinary Medicine.

SPAH previously recognized AADAP, UMESC, and the National Coordinator for Aquaculture New Animal Drug Applications for their contributions to the approval of Aquaflor® for the control of mortality due to enteric septicemia in catfish at Aquaculture America 2006.

(http://www.fda.gov/cvm/CVM_Updates/AquaflorUpdate.htm)