New Approvals...

Schering-Plough Animal Health does it again !!! A huge “Congratulations” is in order to the Schering-Plough Animal Health (SPAH) aquaculture team (and all the other private, public and academic entities that helped with data generation) for adding another claim to their Aquaflor^® medicated feed label. Aquaflor^® is now also approved (as of 6 November 2007) for use in all freshwater-reared salmonids to control mortality caused by furunculosis. Click the following links to view CVM’s Announcment or SPAH’s News Release.

New Aquaflor^® approval for columnaris control in Catfish: Congratulations!! Schering-Plough Animal Health (SPAH) has done it again!! SPAH was notified
(18 April 2007) by the Center for Veterinary Medicine that their AQUAFLOR^® in-feed animal drug has been conditionally approved for the treatment of columnaris in channel catfish. SPAH Press Release FDA announcement

Aquaflor^® (florfenicol) received FDA‑approval for coldwater disease for all freshwater‑reared salmonids: Schering‑Plough Animal Health (SPAH) recently announced (21 March 2007) that Aquaflor^® now has the added approved claim for control of mortality caused by CWD in all freshwater-reared salmonids. Bravo, and thank you, to SPAH for their continued commitment to the U.S. aquaculture community. For more information click here.

FDA approves PEROX-AID^® (hydrogen peroxide) for freshwater-reared finfish and eggs: The U.S. Food and Drug Administration (FDA) has approved 35% PEROX-AID^®, (11 January 2007) an external microbicide for (1) the control of mortality in freshwater-reared finfish eggs due to saprolegniasis, (2) for the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum, and (3) 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 (NADA #141-255) with over the counter marketing status. 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.

CVM approves supplement to Phibro Animal Health's Oxytetracycline NADA (#38-439): The supplement provides for the approval of the dihydrate salt of oxytetracycline, a change of oxytetracycline concentration in the Type A medicated article, and the addition of an indication for control of gaffkemia in lobsters. For more information, view the Federal Register Notice published on 8 August 2006. Phibro Animal Health is to be commended for their efforts in this regard and for supporting the aquaculture industry.

CVM approves florfenicol for ESC: We have all been waiting a long time for this, and it’s finally a reality!!! FDA’s Center for Veterinary Medicine announced on Tuesday, 25 October 2005, that they had approved the NADA submitted by Schering-Plough Animal Health (SPAH) for Aquaflor^® (florfenicol). SPAH’s NADA (#141-246) is an antimicrobial Type-A Medicated Article and, at this time, is limited for the control of mortality due to enteric septicemia of catfish. For more details visit CVM’s website (http://www.fda.gov/cvm/catfishapp.htm) and view Schering-Plough's news release. There are a tremendous number of folks out there deserving of credit for making this happen, and they will be recognized. However, at the moment, suffice to say that none of this would have come about if it had not been for SPAH’s dedication.

A new oxytetracycline product approved for skeletal marking: Pfizer, Inc. ( New York, NY) was recently (18 July 2005) granted an approval to their filed request to supplement their Terramycin-343 (oxytetracycline HCl) Soluble Powder NADA (#8-622) with a finfish skeletal marking claim. See: http://www.fda.gov/cvm/drugsuseaqua.htm, CVM’s website, for more information. There are now three oxytetracycline products approved for skeletal marking in finfish.