February 5, 2007
FDA Approves New Drug for Freshwater-Reared Finfish
This CVM Update was updated February 6, 2007, to replace the word "therapeutant" with "drug" in both the title and second paragraph.
The U.S. Food and Drug Administration (FDA) has approved 35% PEROX-AID®, an external microbicide for the control of mortality in freshwater-reared finfish eggs due to saprolegniasis, for the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum, and for the control of mortality in freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with Flavobacterium columnare (Flexibacter columnaris). 35% PEROX-AID® is approved (New Animal Drug Application 141-255) with over the counter marketing status.
35% PEROX-AID®, a product of Eka Chemicals, Inc., Marietta, Georgia, is the first new immersion drug approved for finfish in twenty years.
35% PEROX-AID® for the approved indications is the second approved aquaculture drug designated under the Minor Use and Minor Species Animal Health Act. This entitles Eka Chemicals, Inc. to seven years of exclusive marketing rights for the approved indications beginning on the date of approval.
The U.S. Geological Survey Upper Midwest Environmental Sciences Center, La Crosse, Wisconsin, generated effectiveness and target animal safety as well as the environmental assessment for the approval (Public Master File 5639).
The FDA reviewed extensive data to ensure the product met all necessary effectiveness, target animal safety, human food safety, and environmental safety standards. The FDA has concluded that fish treated with hydrogen peroxide are safe for human consumption when the fish are treated according to the approved label.
Additional information on this approval may be obtained by contacting Dr. Donald Prater, Division of Therapeutic Drugs for Food Animals, FDA, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, HFV-131, Rockville, MD 20855, 301-827-7567, email: Donald.Prater@fda.hhs.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
|
||||||
 |
||||||
|
||||||