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August 27 2015

United States

Washington DC—Correction on Aquaflor Approval

 

Dr. Dustin R. Moss (dmoss@hpu.edu), a biologist and director of the shrimp research department at the Oceanic Institute in Hawaii, reports: “After seeing your article on Florfenicol [‘Aquaflor’] being approved for treatment of Vibrio, I looked at the FDA listed (at the link you provided) and it doesn’t appear that the drug is approved yet.  It has simply received a designation, which according to the website means:

 

“Designation is a status that makes a pharmaceutical sponsor eligible for incentives to support drug approval.  Designation does not allow the drug to be marketed (sold, promoted, or advertised).  It is illegal to market these products until they are approved or conditionally approved.”

 

Dr. Moss said, “This is just my take on the situation from looking at the FDA website.  I have not confirmed one way or the other with someone from FDA.”

 

Shrimp News: I looked into this and found the following information:

 

“A researcher at Southern Illinois University (SIU)...is working on a project that she and her colleagues around the country hope will satisfy the strict regulations and lead to the first-ever approval of a pharmaceutical ‘tool’ for marine aquaculture operators in the United States.”

 

“Jesse Trushenski, associate professor of zoology at SIU, is working with fellow researchers at Virginia Tech University and government officials at the National Oceanic and Atmospheric Administration and the USA Fish and Wildlife Service Aquatic Animal Drug Approval Partnership Program to test a common fresh-water aquaculture antibiotic—Aquaflor—on two marine species.  The work began this summer with ‘in life’ testing at Virginia Tech, with analysis to follow next year.  Trushenski and SIU are acting as clearinghouse of information and coordinator of the efforts, which are aimed at winning government approval.”

 

“In the case of Aquaflor, its manufacturer already has much of this data available because of its approved use in freshwater aquaculture here, and its use in both freshwater and marine aquaculture in other countries.”

 

Sources: 1. Email to Shrimp News International.  Subject: Drug Approval.  Dustin R. Moss (dmoss@hpu.edu).  August 21, 2015.  2. News.SIU.  Project Could Give Boost to Marine Aquaculture.  Tim Crosby.  August 17, 2015.

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