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Fishery Drug and Development

Progress by drug as of July 31, 1999

progress by drug as of July 31, 1999

Progress made (% complete) toward completing technical section submissions for
each IAFWA project drug and individual label claim from July 1994 to July 1999.


IAFWA Study Number
--Drug (Label Claim)
Product
Chemistry1
Mammalian
Toxicology1
Environ-
mental
Safety1
Human
Food
Safety1
Target
Animal
Safety1
Efficacy1 Total %
Complete
Target
Completion
Date
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1--Formalin (Control of external protozoa and monogenetic trematodes on all fish)

100

100
100
100
100
100
100
100
10
100
10
100
70
100
Approved
6-98
1--Formalin (Control or prevent fungi of the family Saprolegniaceae on all fish eggs)
100
100
100
100
100
100
100
100
10
100
10
100
70
100
Approved
6-98
1--Formalin (Control or prevent fungi of the family Saprolegniaceae on coldwater fish)
100
100
100
100
100
100
100
100
100
100
0
90
83
98
Submitted
4-98
1--Formalin (Control or prevent fungi of the family Saprolegniaceae on all fish)
100
100
100
100
100
100
100
100
25
100
0
50
71
92
2000

IAFWA Study Number
--Drug (Label Claim)
Product
Chemistry1
Mammalian
Toxicology1
Environ-
mental
Safety1
Human
Food
Safety1
Target
Animal
Safety1
Efficacy1 Total %
Complete
Target
Completion
Date
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
2--Oxytetracycline (Control of Aeromonas sp. in coolwater fish)
100
100
100
100
100
100
0
70
100
100
0
90
67
93
Submitted
2-99
2--Oxytetracycline (Control of systemic coldwater disease, Flavobacterium psychrophilum in coldwater fish)
100
100
100
100
100
100
0
90
100
100
0
50
67
90
2001
2--Oxytetracycline (Control of columnaris disease, Flavobacterium columnare, in coldwater fish)
100
100
100
100
100
100
0
100
100
100
0
25
67
88
2001
2--Oxytetracycline (Control of systemic columnaris disease in cool- and warmwater fish)
100
100
100
100
100
100
0
70
100
100
0
15
67
81
2002
2--Oxytetracycline (Marking of skeletal tissue of cool- and warmwater fish)
100
100
100
100
100
100
0
100
100
100
0
85
67
98
1999

IAFWA Study Number
--Drug (Label Claim)
Product
Chemistry1
Mammalian
Toxicology1
Environ-
mental
Safety1
Human
Food
Safety1
Target
Animal
Safety1
Efficacy1 Total %
Complete
Target
Completion
Date
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
3--Copper sulfate (Control of Ichthyopthirius on all fish) 3
0
100
90
100
50
90
50
100
50
90
25
100
44
97
1999
3--Copper sulfate (Control of external parasites (other than "Ich")
0
100
90
100
50
90
50
100
50
90
25
15
44
83
2001
3--Copper sulfate (Control or prevent bacterial and fungal infections on all fish)
0
100
90
100
50
90
50
100
50
90
25
15
44
83
2001

IAFWA Study Number
--Drug (Label Claim)
Product
Chemistry1
Mammalian
Toxicology1
Environ-
mental
Safety1
Human
Food
Safety1
Target
Animal
Safety1
Efficacy1 Total %
Complete
Target
Completion
Date
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
4--Chloramine-T (Control of bacterial gill disease, Flavobacterium branchiophilum, on coldwater fish) 3
0
10
25
70
10
25
10
60
0
10
0
75
8
42
2000
4--Chloramine-T (Control of bacterial gill disease on cool- and warmwater fish)
0
10
25
70
10
25
10
60
0
10
0
15
8
32
2001
4--Chloramine-T (Control of external coldwater disease, Flavobacterium psychrophilum, on coldwater fish)
0
10
25
70
10
25
10
70
0
10
0
15
8
33
2001
4--Chloramine-T (Control of external columnaris disease, Flavobacterium columnare, on coldwater fish)
0
10
25
70
10
25
10
70
0
10
0
15
8
33
2001
4--Chloramine-T (Control of external columnaris disease on cool- and warmwater fish)
0
10
25
70
10
25
10
70
0
10
0
15
8
33
2002

IAFWA Study Number
--Drug (Label Claim)
Product
Chemistry1
Mammalian
Toxicology1
Environ-
mental
Safety1
Human
Food
Safety1
Target
Animal
Safety1
Efficacy1 Total %
Complete
Target
Completion
Date
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
5--Sarafloxacin (replaced by florfenicol--Control furunculosis, Aeromonas salmonicida, in Atlantic salmon) 3,4
0
NA
0
NA
0
NA
0
NA
0
NA
0
NA
0
NA
NA
5--Florfenicol (Control of systemic coldwater disease, Flavobacterium psychrophilum, in coldwater fish) 4
0
50
0
100
0
25
0
50
0
50
0
0
0
46
2002
5--Florfenicol (Control of columnaris disease, Flavobacterium columnare, in all fish) 4
0
50
0
100
0
25
0
15
0
15
0
0
0
34
2002
5--Florfenicol (Control of enteric septicemia, Edwardsiella ictaluri, in catfish) 4
0
50
0
100
0
25
0
15
0
0
0
10
0
33
2002
5--Florfenicol (Control of motile aeromonas septicemia in all fish) 4
0
50
0
100
0
25
0
15
0
15
0
0
0
34
2002
5--Florfenicol (Control of streptococcal disease, Streptococcus sp. in striped bass) 4
0
50
0
100
0
25
0
15
0
0
0
0
0
32
2002

IAFWA Study Number
--Drug (Label Claim)
Product
Chemistry1
Mammalian
Toxicology1
Environ-
mental
Safety1
Human
Food
Safety1
Target
Animal
Safety1
Efficacy1 Total %
Complete
Target
Completion
Date
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
6­Potassium permanganate (Control fungi of the family Saprolegniaceae on all fish) 3
0
90
75
75
50
90
50
90
10
40
10
10
33
66
2001
6--Potassium permanganate (Control external parasites on all fish)
0
90
75
75
50
90
50
90
10
40
10
10
33
66
2002
6--Potassium permanganate (Control or prevent external bacteriosis on all fish)
0
90
75
75
50
90
50
90
10
40
10
10
33
66
2002

IAFWA Study Number
--Drug (Label Claim)
Product
Chemistry1
Mammalian
Toxicology1
Environ-
mental
Safety1
Human
Food
Safety1
Target
Animal
Safety1
Efficacy1 Total %
Complete
Target
Completion
Date
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
7--Benzocaine (replaced by AQUI-S--zero or low withdrawal anesthetic for Atlantic salmon) 3, 5
0
50
0
25
0
50
0
25
0
50
0
50
0
42
2000
7--AQUI-S (Zero or low withdrawal anesthetic for all fish) 5
0
50
0
25
0
50
0
25
0
25
0
25
0
33
2002

IAFWA Study Number
--Drug (Label Claim)
Product
Chemistry1
Mammalian
Toxicology1
Environ-
mental
Safety1
Human
Food
Safety1
Target
Animal
Safety1
Efficacy1 Total %
Complete
Target
Completion
Date
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
1994
1999
8­Hydrogen peroxide (Control or prevent fungi of the family Saprolegniaceae on all fish eggs) 3
0
50
90
100
10
50
90
100
10
90
10
90
35
80
1999
8--Hydrogen peroxide (Control or prevent fungi of the family Saprolegniaceae on all fish)
0
50
90
100
10
50
90
100
10
75
10
90
35
78
2000
8--Hydrogen peroxide (Control or prevent external bacteriosis on all fish)
0
50
90
100
10
50
90
100
10
75
0
50
33
71
2001
8--Hydrogen peroxide (Control external parasites of all fish)
0
50
90
100
10
50
90
100
10
75
0
50
33
71
2001

 

1 Responsible entities: product chemistry - sponsor; mammalian toxicology - sponsor; environmental safety - IAFWA/sponsor; human food safety - IAFWA/sponsor; target animal safety - IAFWA (except for coldwater fish treated with chloramine-T); efficacy - FWS/states/IAFWA/sponsor.

2 Target completion date is the year estimated that all the technical sections needed for approval will be submitted to the Center for Veterinary Medicine for a specific label claim.

3 These label claims are for the initial approval of a new drug and therefore involve more effort than a supplemental claim such as those that follow.

4 Sarafloxacin/florfenicol: work was nearly complete to gain an approval for sarafloxacin to control environmental septicemia in channel catfish in 1995 when the Centers for Disease Control and Prevention raised the issue of antimicrobial resistance of human pathogens as an emerging problem. This blocked the approval of sarafloxacin and a replacement, florfenicol, was identified in January of 1998. Research on florfenicol was delayed until 1999 due to circumstances beyond the control of the IAFWA Project.

5 Benzocaine/AQUI-S : based on a poll of IAFWA Project stakeholders, AQUI-S replaced benzocaine in 1997. Extensive human food safety data requirements for benzocaine were nearly complete in 1996 but no sponsor was available meaning two costly mammalian safety studies would have to be funded by the IAFWA Project. AQUI-S was chosen because it was potentially an anesthetic with a "zero" withdrawal time, it had a willing sponsor, and costly safety data would not be required. Research on AQUI-S was delayed until 1999 due to circumstances beyond the control of the IAFWA Project.

 

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