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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. |