CONTENT AND FORMAT OF REQUEST FOR DESIGNATED NEW ANIMAL DRUG

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					          AQUACULTURE DRUG APPROVAL DEVELOPMENT STATUS


OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH): RESEARCH
AND DEVELOPMENT PLAN AND LABEL CLAIM MATRICES FOR
SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION (NADA) APPROVALS

1. Oxytetracycline dihydrate (Terramycin® for Fish) NADA approvals (9/23/70,
   6/30/06; 7/6/08)
2. Status of Technical Sections that support all supplemental NADA approvals
3. Label Claim #1: Skeletal marking of salmonids
4. Label Claim #2: Control of mortality in freshwater-reared finfish due to
   columnaris disease
5. Label Claim #3: Control of mortality in coolwater and warmwater finfish due
   to motile aeromonad septicemia
6. Label Claim #4: Control of mortality in penaeid shrimp due to necrotizing
   hepatopancreatitus


DEVELOPED UNDER THE FEDERAL-STATE AQUACULTURE DRUG APPROVAL
 PARTNERSHIP PROJECT, A PROJECT OF THE ASSOCIATION OF FISH AND
                      WILDLIFE AGENCIES


                               Rosalie A. Schnick
      National Coordinator for Aquaculture New Animal Drug Applications
                           Michigan State University
            3039 Edgewater Lane, La Crosse, Wisconsin 54603-1088
                   Phone (608) 781-2205; Fax (608) 783-3507
                      E-mail: RozSchnick@centurytel.net
                    Website: http://aquanic.org/aquadrugs



         OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH)
                      (Version 5, February 25, 2010)
               ABBREVIATIONS, ACRONYMS, & CONTACT INFORMATION FOR ENTITIES IN TABLE
               Aquatic Animal Drug Approval Partnership Program—Dr. David Erdahl, U.S. Fish and Wildlife
               Service, 4050 Bridger Canyon Road, Bozeman, Montana 59715; Phone: 406-994-9904; Fax: 406-
  AADAP        582-0242; E-mail: Dave_Erdahl@fws.gov
               All Other Information Technical Section, not included in any of the other sections, that is pertinent to
    AOI        an evaluation of effectiveness or safety [21 CFR § 514.1(b)(8)(iv)]

               Aquaculture Drugs Team (HFV-131), Division of Therapeutic Drugs for Food Animals, Office of New
               Animal Drug Evaluations, Center for Veterinary Medicine, U.S. Food and Drug Administration, 7500
               Standish Place, Rockville, MD 20855; Dr. Jennifer Matysczak; Phone: 240-276-8338; E-mail:
    CVM        jennifer.matysczak@fda.hhs.gov

               Effectiveness Technical Section includes pivotal & supportive studies that show whether or not a drug
  Efficacy     is effective for its intended use [21 CFR § 514.1(b)(8)(i)]

               Final Freedom of Information summary generated by CVM based on draft FOIs developed by
    FOI        researchers for each study [21 CFR § 514.11(e)(2)(ii)]

   INAD        Investigational New Animal Drug exemption [21 CFR 511]

   Label       Labeling Technical Section includes labeling and package inserts [21 CFR § 514.1(b)(3)]

   NADA        New Animal Drug Application [21 CFR 514]

               Rosalie (Roz) Schnick, National Coordinator for Aquaculture New Animal Drug Applications, Michigan
   NADA        State University, 3039 Edgewater Lane, La Crosse, Wisconsin 54603-1088; Phone: 608-781-2205;
 Coordinator   Fax: 608-783-3507; E-mail: RozSchnick@centurytel.net

               Sponsor of oxytetracycline dihydrate (Terramycin® 200 for Fish): Paul F. Duquette, Director, Global
               Regulatory Affairs, Phibro Animal Health, 65 Challenger Road, 3rd floor, Ridgefield Park, NJ 07660;
  PHIBRO       Phone: 201-329-7375; E-mail: paul.duquette@pahc.com;

  Product      Product Chemistry Technical Section includes chemistry, manufacturing, and controls [21 CFR §
 Chemistry     514.1(b)(4-6)]

               Public Master File can contain safety and efficacy data and information generated with public funds
    PMF        (Guidance Document #57)

               Part of Human Food Safety Technical Section, toxicological testing includes genetic toxicity tests and
 Toxicology    mammalian safety studies (e.g., acute, subchronic) (Guidance Document #3)

               University of Arizona; Rodney Williams, Department of Veterinary Sciences, Tucson, AZ 85721;
    UAZ        Phone: 602-293-3502; Fax: 602-293-3502; E-mail: rodneyw@Ag.arizona.edu

               Upper Midwest Environmental Sciences Center—Mark Gaikowski, 2630 Fanta Reed Road, La
  UMESC        Crosse, Wisconsin 54603; Phone: 608-783-6451; Fax: 608-783-6066; E-mail: MGaikowski@usgs.gov

KEY TO COLOR CODING

                      COLOR                                                   STATUS
                                                         No current plans and/or funds
                                                         In progress or planned; funded
                                                         Submitted to CVM
                                                         Accepted by CVM




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                          OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH)

                Oxytetracycline dihydrate (Terramycin® for Fish) NADA approvals (9/23/70, 6/30/06)


ORIGINAL NADA APPROVAL FOR MONO-ALKYL TRIMETHYL AMMONIUM OXYTETRACYCLINE (TERRAMYCIN®
FOR FISH) (9/23/70)

Species/Class: Salmonids, catfish, and lobsters

Indications:
Salmonids: Control of ulcer disease caused by Hemophilus piscium, furunculosis caused by Aeromonas
salmonicida, bacterial hemorrhagic septicemia caused by Aeromonas liquifaciens, and pseudomonas disease
Catfish: For the control of bacterial hemorrhagic septicemia caused by Aeromonas liquifaciens and pseudomonas
disease in catfish
Lobsters: Control of Gaffkemia caused by Aerococcus viridans

Recommended Dosage:
Salmonids and catfish: 2.5 to 3.75 g of oxytetracycline per100 lb of fish for 10 consecutive days
Lobsters: 1 g oxytetracycline/lb of medicated feed administered as the sole ration for 5 consecutive days

Species/Class: Pacific salmon
Indications: For marking of skeletal tissue
Recommended Dosage: 250 mg of oxytetracycline per kg of fish per day in fish feed


SUPPLEMENTAL NADA APPROVAL FOR OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN 200® FOR FISH)
(6/30/06)

This supplement provides for the change of the active ingredient from the mono-alkyl (C8-C18) trimethylammonium
oxytetracycline to the oxytetracycline dihydrate, the change of the oxytetracycline concentration from 100 g/lb to 200 g/lb,
the change of the product name to reflect the change in the oxytetracycline concentration, and the addition of the
approved lobster indication to the label for the control of Gaffkemia caused by Aerococcus viridans.


SUPPLEMENTAL NADA APPROVAL FOR OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN 200® FOR FISH)
(7/6/08)

Species/Class: Freshwater-reared salmonids

Indications:
Freshwater-reared salmonids: Control of mortality due to coldwater disease associated with Flavobacterium
psychrophilum

Recommended Dosage:
Freshwater-reared salmonids: 3.75 g of oxytetracycline per100 lb of fish for 10 consecutive days. Can treat salmonids
below 9°C.

Species/Class: Freshwater-reared Oncorhynchus mykiss

Indications:
Freshwater-reared Oncorhynchus mykiss: Control of mortality due to columnaris disease associated with
Flavobacterium columnare

Recommended Dosage:
Freshwater-reared salmonids: 3.75 g of oxytetracycline per100 lb of fish for 10 consecutive days. Can treat salmonids
below 9°C.




                                                             3
                          OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH)

                      Status of Technical Sections that support all supplemental NADA approvals
      Technical Section                           Entity—Data—Action                       Impediments or Cost—
                                                                                                  Action
Product Chemistry                 PHIBRO (INAD #11-368)—Product chemistry                  None
(quaternary ammonium salt)        package/ quaternary ammonium salt—previously
                                  accepted
Product Chemistry (dihydrate      PHIBRO (INAD #11-368)—Product chemistry                  None—Technical
salt)                             package/change quaternary ammonium salt to               Section is complete
                                  dihydrate salt—accepted 6/30/06
Environmental Safety (pond,       PHIBRO (INAD #11-368) & others—Environmental             None
flow-through, & recirculating     assessment—previously accepted
systems)
Environmental Safety (pond,       UMESC (INAD #11-366 & PMF #5646)—                        None
flow-through, & recirculating     Environmental assessment/all finfish—accepted
systems/all finfish)              2/21/08
Human Food Safety—                PHIBRO (INAD #11-368) & others—Toxicology—               None
Toxicology                        previously accepted
Human Food Safety—                PHIBRO (INAD #11-368) & others—Residue                   None
Residue Chemistry                 depletion studies in salmonids and catfish—
(salmonids & catfish)             previously accepted
Human Food Safety—                UMESC (INAD #11-366 & PMF #5646)—Bridged                 None
Residue Chemistry (rainbow        official microbial inhibition assay with HPLC
trout)                            method/rainbow trout—accepted 9/11/97
Human Food Safety—                UMESC (INAD #11-366 & PMF #5646)—Liquid                  None
Residue Chemistry (all            chromatographic determination/six fish species
finfish)                          fillets—accepted 12/8/00 & follow-up response
                                  9/9/02
Human Food Safety—                UMESC (INAD #11-366 & PMF #5646)—Bridged                 None
Residue Chemistry (all            official microbial inhibition assay with robust HPLC
finfish)                          method/all finfish—accepted 12/8/00 & follow-up
                                  response 9/9/02; final acceptance 10/27/04
Human Food Safety—                UMESC (INAD #11-366 & PMF #5646)—Marker                  None
Residue Chemistry (all            residue depletion studies for all juvenile freshwater-
freshwater-reared salmonids)      reared salmonids below 9° C—accepted 9/9/99
Human Food Safety—                UMESC (INAD #11-366 & PMF #5646)—Extrapolated            None
Residue Chemistry (all            withdrawal times for all sizes of salmonids—
salmonids)                        accepted 5/17/02
Human Food Safety—                AADAP (INAD #9332)—Microbial food safety/ Hazard         None
Microbial Food Safety #152        Characterization/Evaluating the safety of drugs to
(freshwater-reared                their microbiological effects on bacteria of human
salmonids)                        health concern (Guidance Document
                                  #152)/freshwater-reared salmonids—Accepted
                                  3/15/07
Human Food Safety—                PHIBRO (INAD #11-368), UMESC, & NADA                     None
Microbial Food Safety #159        Coordinator—Microbial food safety/Assessment of
(all freshwater-reared finfish)   the effect of residues on the human intestinal flora
                                  (Guidance Document #159)/all freshwater-reared
                                  finfish)—accepted 9/20/06
Human Food Safety                 PHIBRO (INAD #11-368)—Human Food                         None—Technical
(Technical Section Complete       Safety/Technical Section Complete Letter—                Section is complete
Letter)                           accepted 2/6/08
Target Animal Safety (catfish     PHIBRO (INAD #11-368) & others—Target animal             None
and salmonids)                    safety/salmonids and catfish—previously accepted
Target Animal Safety (all         UMESC (INAD #11-366 & PMF #5646)—Target animal           None—Technical
freshwater-reared finfish)        safety/all freshwater-reared finfish—accepted            Section is complete
                                  12/19/03

                                                          4
Efficacy (all label claims/all   UMESC (INAD #11-366 & PMF #5646)—Developed            None
finfish)                         analytical method to detect oxytetracycline in feed
                                 in support of all INAD testing—accepted 7/29/98




                                                         5
   SUPPLEMENTAL NADA APPROVAL FOR OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH)
                                    APPROVED 7/6/08

Species/Class: Freshwater-reared salmonids
Indications:
Freshwater-reared salmonids: Control of mortality due to coldwater disease associated with Flavobacterium
psychrophilum
Recommended Dosage:
Freshwater-reared salmonids: 3.75 g of oxytetracycline per100 lb of fish for 10 consecutive days. Can treat salmonids
below 9°C.

Species/Class: Freshwater-reared Oncorhynchus mykiss
Indications:
Freshwater-reared Oncorhynchus mykiss: Control of mortality due to columnaris disease associated with
Flavobacterium columnare
Recommended Dosage:
Freshwater-reared salmonids: 3.75 g of oxytetracycline per100 lb of fish for 10 consecutive days. Can treat salmonids
below 9°C.

                                                                                              Impediments or
Technical Section                 Entity—Data—Action                                          Cost—Action
Efficacy (coldwater               UMESC (INAD #11-366 & PMF #5646)—                           None
disease/freshwater-reared         Efficacy/coldwater disease/all freshwater-reared
salmonids)                        salmonids—accepted Data Call-in as supportive
                                  2/1/00
Efficacy (coldwater               AADAP (INAD #9006 & 9332)—Efficacy/coldwater                None—Technical
disease/freshwater-reared         disease/all freshwater-reared salmonids—accepted as         Section is complete
salmonids)                        pivotal 11/23/01
Efficacy (columnaris              UMESC (INAD #11-366 & PMF #5646)—                           None
disease/freshwater-reared         Efficacy/columnaris disease/all freshwater-reared
salmonids)                        salmonids—accepted Data Call-in as supporting
                                  2/1/00
Efficacy (columnaris              AADAP (INAD #9006 & 9332)—Efficacy/columnaris               None
disease/steelhead trout)          disease/steelhead trout—accepted as pivotal 11/14/00
Efficacy (columnaris              AADAP (INAD #9006 & 9332)—Efficacy/columnaris               None—Technical
disease/freshwater-reared         disease/freshwater-reared Oncorhynchus mykiss—              Section is complete
Oncorhynchus mykiss)              accepted for all freshwater-reared Oncorhynchus
                                  mykiss—accepted 7/25/07
Label                             PHIBRO (INAD #11-368) & NADA Coordinator—                   None—Technical
                                  Label/coldwater disease/freshwater-reared salmonids         Section is complete
                                  & columnaris disease/freshwater-reared
                                  Oncorhynchus mykiss—accepted 5/8/08
FOI                               CVM—FOI/coldwater disease/freshwater-reared                 None
                                  salmonids & columnaris disease/freshwater-reared
                                  Oncorhynchus mykiss—accepted 5/23/08
AOI                               PHIBRO (INAD #11-368) & NADA Coordinator—                   None
                                  AOI/coldwater disease/freshwater-reared salmonids &
                                  columnaris disease/freshwater-reared Oncorhynchus
                                  mykiss—accepted 5/23/08
NADA Package                      PHIBRO (INAD #11-368) & NADA Coordinator—NADA               None—approval is
                                  package/coldwater disease/freshwater-reared                 complete
                                  salmonids & columnaris disease/freshwater-reared
                                  Oncorhynchus mykiss—approved 7/5/08




                                                           6
                        OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH)

LABEL CLAIM #1
SPECIES: SALMONIDS
INDICATIONS: For skeletal marking of salmonids
DIRECTIONS FOR USE: Apply Terramycin® 200 for Fish in medicated feed at a dose of 11.35 grams oxytetracycline per
100 pounds of fish (250 mg per kg of fish) per day for four consecutive days.

                                                                                        Impediments or
Technical Section               Entity—Data—Action                                      Cost—Action
Efficacy (skeletal              AADAP (INAD #9006 & 9332)—Efficacy/skeletal             None
marking/salmonids)              marking/salmonids—accepted 1/29/10
Label                           PHIBRO (INAD #11-368)—Label/ skeletal                   None—pending
                                marking/salmonids—in progress                           acceptance
FOI                             CVM—FOI/skeletal marking/salmonids—in progress          None—pending
                                with PHIBRO, UMESC, & AADAP input                       acceptance
AOI                             PHIBRO (INAD #11-368)—AOI/ skeletal                     None—pending
                                marking/salmonids—in progress                           acceptance
NADA Package                    PHIBRO (INAD #11-368)—NADA package/skeletal             None—pending
                                marking/salmonids—in progress                           acceptance




                                                        7
                            OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH)

LABEL CLAIM #2
SPECIES: FRESHWATER-REARED FINFISH
INDICATIONS: For the control of mortality in freshwater-reared finfish due to systemic columnaris disease
associated with Flavobacterium columnare (Flexibacter columnaris)
DIRECTIONS FOR USE: Apply Terramycin® 200 for Fish in medicated feed at a dose of 3.75 grams oxytetracycline per
100 pounds of fish per day for ten consecutive days.

        Technical Section                       Entity—Data—Action                     Impediments or Cost—
                                                                                              Action
Efficacy (columnaris              UMESC (INAD #11-366 & PMF #5646)—                    None
disease/salmonids)                Efficacy/columnaris disease/all freshwater-reared
                                  salmonids—accepted Data Call-in as supporting
                                  2/1/00
Efficacy (columnaris              AADAP (INAD #9006 & 9332)—Efficacy/columnaris        None
disease/steelhead trout)          disease/steelhead trout—accepted as pivotal
                                  11/14/00
Efficacy (columnaris              AADAP (INAD #9006 & 9332)—Efficacy/columnaris        None—pending
disease/salmonids)                disease/Coho salmon or Chinook salmon—planned        acceptance
Efficacy (columnaris              No entity identified—Pivotal efficacy/columnaris     Needs to be planned
disease/coolwater &               disease/coolwater & warmwater fish—not planned
warmwater fish)
Label                             PHIBRO (INAD #11-368)—Label/columnaris               None—pending
                                  disease/freshwater-reared finfish—i planned if       acceptance
                                  efficacy accepted
FOI                               CVM—FOI/columnaris disease/freshwater-reared         None—pending
                                  finfish—planned if efficacy accepted                 acceptance
AOI                               PHIBRO (INAD #11-368)—AOI/columnaris                 None—pending
                                  disease/freshwater-reared finfish—planned if         acceptance
                                  efficacy accepted
NADA Package                      PHIBRO (INAD #11-368)—NADA                           None—pending
                                  package/columnaris disease/freshwater-reared         acceptance
                                  finfish—planned if efficacy accepted




                                                        8
                            OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH)

LABEL CLAIM #3
SPECIES: COOLWATER AND WARMWATER FINFISH
INDICATIONS: For the control of mortality in coolwater and warmwater finfish due to motile aeromonad
septicemia associated with Aeromonas hydrophila
DIRECTIONS FOR USE: Apply Terramycin® 200 for Fish in medicated feed at a dose of 3.75 grams oxytetracycline per
100 pounds of fish per day for ten consecutive days.

        Technical Section                        Entity—Data—Action                    Impediments or Cost—
                                                                                              Action
Efficacy (bacterial               PHIBRO (INAD #11-368) & others—Efficacy/bacterial    None
hemorrhagic                       hemorrhagic septicemia/salmonids and catfish—
septicemia/catfish and            previously accepted
salmonids)
Efficacy (Aeromonas               UMESC (PMF #5646)—Efficacy/Aeromonas                 None
sp./northern pike)                sp./northern pike—accepted Data Call-in as
                                  supportive 2/1/00

Efficacy (motile aeromonad        UMESC & PHIBRO—Pivotal efficacy/motile               None—pending
septicemia/coolwater and          aeromonad septicemia/coolwater and warmwater         acceptance
warmwater finfish)                finfish—in progress with NCRAC funds
Label                             PHIBRO (INAD #11-368)—Label/motile aeromonad         None—pending
                                  septicemia/coolwater and warmwater finfish—          acceptance
                                  planned when efficacy accepted
FOI                               CVM—FOI/motile aeromonad septicemia/coolwater        None—pending
                                  and warmwater finfish—planned when efficacy          acceptance
                                  accepted
AOI                               PHIBRO (INAD #11-368)—AOI/motile aeromonad           None—pending
                                  septicemia/coolwater and warmwater finfish—          acceptance
                                  planned when efficacy accepted
NADA Package                      PHIBRO (INAD #11-368)—NADA package/motile            None—pending
                                  aeromonad septicemia/ coolwater and warmwater        acceptance
                                  finfish—planned when efficacy accepted




                                                         9
                            OXYTETRACYCLINE DIHYDRATE (TERRAMYCIN® 200 FOR FISH)

LABEL CLAIM #4
SPECIES: PENAEID SHRIMP
INDICATIONS: For the control of mortality in penaeid shrimp due to necrotizing hepatopancreatitus
DIRECTIONS FOR USE: Apply Terramycin® 200 for Fish in medicated feed at a dose of 1.5 to 4.5 grams oxytetracycline
per kilograms of feed per day for 14 consecutive days.

        Technical Section                        Entity—Data—Action                     Impediments or Cost—
                                                                                               Action

Environmental Safety (pond,       UAZ (INAD #8069)—Environmental assessment             None—pending
flow-through, & recirculating     additional data/penaeid shrimp—in progress            acceptance
systems/penaeid shrimp)

Human Food Safety—                PHIBRO (INAD #11-368)—Mammalian toxicology—           None—pending
Toxicology (penaeid shrimp)       needs to provide proprietary data to derive ADI for   acceptance
                                  penaeid shrimp

Human Food Safety—                UAZ (INAD #8069)—Residue Chemistry/penaeid            None
Residue Chemistry (penaeid        shrimp—accepted 11/4/99
shrimp)

Human Food Safety—                PHIBRO (INAD #11-368) & UAZ—Microbiological           None
Microbiological toxicology of     toxicology of residues—Guideline # 159/penaeid
residues (penaeid shrimp)         shrimp—Paper argument to add to other NADAs (8-
                                  804 & 95-143) for aquaculture NADAs—accepted
                                  8/15/06

Human Food Safety—                PHIBRO (INAD #11-368) & UAZ—Microbial food            None—pending
Microbial Food Safety             safety—Guideline #152/ freshwater-reared              acceptance
(penaeid shrimp)                  salmonids—Qualitative Risk Assessment—in
                                  progress

Target Animal Safety              UAZ (INAD #8069)—Target animal safety/penaeid         None—pending
(penaeid shrimp)                  shrimp—submitted 8/04; CVM responded by               acceptance; funding
                                  requesting more data; Texas Agrilife Research         through MUMS grant
                                  Mariculture Laboratory obtained funding               11/3/09

Efficacy (necrotizing             UAZ (INAD #8069)—Efficacy/necrotizing                 None
hepatopancreatitus/penaeid        hepatopancreatitus/penaeid shrimp—accepted
shrimp)                           6/28/00

Label                             PHIBRO (INAD #11-368)—Label/necrotizing               None—pending
                                  hepatopancreatitis/penaeid shrimp—planned             acceptance


FOI                               CVM—FOI/necrotizing hepatopancreatitus/penaeid        None—pending
                                  shrimp—planned with PHIBRO & UAZ input                acceptance

AOI                               PHIBRO (INAD #11-368)—AOI/ necrotizing                None—pending
                                  hepatopancreatitis/penaeid shrimp—planned             acceptance

NADA Package                      PHIBRO (INAD #11-368)—NADA                            None—pending
                                  package/necrotizing hepatopancreatitis/penaeid        acceptance
                                  shrimp—planned




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