Application Summary for Application No 47910...

AUSTRALIAN PESTICIDES & VETERINARY MEDICINES AUTHORITYApplication Summary for Application No 47910

Created on: 26 Feb 2013 11:09 AM of 33 Application Summary 4

Application Details:

Application Purpose and Description of Use:

Registration of a 10mg/mL derquantel, 1mg/mL abamectin oral anthelmintic product for treatment and control of nematodes in sheep, in conjunction with approval of derquantel.

Active Constituent Name

Reference Product Number Reference Product Name

64247Product No:

STARTECT BROAD SPECTRUM ORAL DRENCH FOR SHEEPProduct Name:

PFIZER ANIMAL HEALTH AUSTRALIA PTY LTDApplicant Name:

Description of Data Provided

Data NoApplicants Reference Author Title Date Publication Authorising Party

Auth Party Contact Address

36548

36738

36737

21 Jan 09 #7A-1 & 7B-1

A28.0

1-44 to 1-45

Greening, R.

Anon

Anon

Environmental Impact Assessment for STARTECT© Oral Drench

Appearance of Solid Substances

Range of Analytical Test Results for Derquantel API

22 Jan 09

3 March 1986

June 2009

-

-

-

Applicant

Applicant

Applicant

38-42 WHARF ROAD WEST RYDE NSW 2114







36736

36735

36734

36733

36732

36731

36730

36729

36728

1-36

1-32 to 1-35

#3-66

#3-65

#3-64

#3-63

#3-62

#3-61

#3-60

Anon

Anon

Malbert, C.H., et al

Niinist”, K.E., et al

Capen, C.C.

Boone, L., et al

Greaves, P.

Broadley, K.J.

Hurst, R.S.

Process Controls

Method of Manufacture

Pathophysiology of the gastrointestinal tract

Plasma levels of heat shock protein 72 (HSP72) and -endorphin as indicators of stress, pain and prognosis in horses with colic

Mechanistic data and risk assessment of selected toxic end points of the thyroid glandSelection and interoperation of clinical pathology indicators of hepatic injury in preclinical studies

Liver and pancreas

Drugs affecting autonomic ganglia (Including the adrenal medulla)

Nicotinic acetylcholine receptor high throughput receptor screening assay summary for derquantel (PF-00520904) and paraherquamide (PF-03198957).

June 2009

2009

2004

2009

1997

2005

2007

1996

23 Apr 2009

-

-

Dunlop RH, Malbert CH, editors. Veterinarypathophysiology. Ames (IA): Blackwell, 2004: 111-142

The Veterinary Journal2009;doi:10.1016/j.tvjl.2009.01.011

Toxicol Pathol 1997;25(1):39-48

Vet ClinPathol 2005;34: 182-88

Histopathology of preclinical toxicity studies. 3rd edition, Chapter 9. Elsevier Ltd 2007: 457-528

Autonomic Pharmacology, Chapter 11. Taylor and Francis, 1996: 413-44

-

Applicant

Applicant

Public

Public

Public

Public

Public

Public

Applicant


38-42 WHARF ROAD WEST RYDE NSW 2114 -

-

-

-

-

-






36727

36726

36739

36725

36740

36742

36755

36754

36753

36752

36751

#3-59

1471N-60-08-512#3-58

I 5.8

1471R 60-07-500#3-57

GP 0507

GP0502

2-17

SOP-4.2.2-020

SOP-4.2.2-039

ATM-0239

1-162 to 1-169

Young, J.M., et al.

May, J.R.

Anon

May, J.R.

Anon

Anon

Anon

Argenta

Argenta

Argenta

Anon

Mecamylamine: New therapeutic uses and toxicity/risk profile.Pharmacological characterization of the effects of the anthelmintic paraherquamide, PF-00520904 and PF-03198957, on nicotinic acetylcholine receptors endogenously expressed on neurons isolated from rat and dog dorsal root ganglion

Fourier Transform Infrared Spectroscopy (General Method)

Model development of nicotinic acetylcholine receptors isolated from rat and dog ganglion

General Procedure for Karl Fischer (KF) Moisture Determination

General Residual Solvent Method with Validation Report

Degradation Products Associated with Derquantel/Abamectin Oral Solution

pH (10% w/v) at 20 C

Identification (IR Scan)

Visual Inspection (Appearance) Test

Batch Analysis - Derquantel

2001

04 Mar 2009

20 May 2005

11 Mar 2009

20 September 2006June 2009

June 2009

June 2009

June 2009

June 2009

June 2009

Clin Therap 2001; 23:532-65-

-

-

-

-

-

-

-

-

-

Public

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

-




38-42 WHARF ROAD WEST RYDE NSW 2114 38-42 WHARF ROAD WEST RYDE NSW 2114









36750

36749

36748

36747

36746

36745

36744

36743

36741

36724

36723

1-162 to 1-169

1-159 to 1-161

1-157 to 1-158

1-147 to 1-152

1-140 to 1-146

1-131 to 1-135

RPD 78300-01

R 2.0

TA 2492

#3-56

1471N-60-08-564#3-54

Anon

Anon

Anon

Anon

Anon

Anon

Anon

G Maccari

Anon

Dupuis, P.

Mecchi, M.S.

Batch Analysis - Derquantel

Impurities Associated with Manufacture of Derquantel

Reference Standards - Analytical Test Results

Physicochemical Characteristics

Development Chemistry

Manufacturing Process Development

Regulatory Process Description

Determination of Residue on Ignition by Sulfated Ash with Validation Report

Assay and Purity Evaluation of PF-00520904 Active Pharmaceutical Ingredient by HPLC with Validation ReportStudy of PNU-141962 in various binding, signal transduction and functional monoamine uptake assays. Cerep Study No. 4021

Bacterial reverse mutation assay with a confirmatory assay

June 2009

June 2009

June 2009

June 2009

June 2009

June 2009

December 2008

10 May 2006

June 2009

23 Dec 1999

27 Feb 2009

-

-

-

-

-

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant













36722

36703

36702

36701

36700

36699

36698

36697

36696

36695

36694

1471N-60-08-592#3-53

1471N-45-05-316#3-34

1471N-60-08-563#3-33

1471R-60-07-494#3-32

1461N-60-08-836#3-31

1462R-60-05-702#3-301471N-60-08-562#3-29

1471N-14-04-310#3-28

1471N-14-04-309#3-27

a0044881 #3-26

1471R-60-08-586 #3-25

Mecchi, M.S.

Goldenthal, A.

May, J.R.

May, J.R.

May, J.R.

Savides, M.C.

May, J.R.

Rozinova, E.

Brook, F.

Seaman, W.J.

Lowney, C.A.

Bacterial reverse mutation assay with a confirmatory assay

90-Day toxicity test of PF-520904 in rats. Estendart Ltd Study No. EL55056

1-Month oral toxicity study of 2-DOPH/ Abamectin (Startect) in rats

7-Day oral dose range-finding study of combination abamectin/2-desoxo paraherquamide (PF-00520904) in rats

A 1-month oral toxicity study of PF-00520904 in dogs

28-Day preliminary oral toxicity study in dogs with PF-00520904.1-Month oral toxicity study of PF-00520904 enriched with 4% PF- 03768626 (N-oxide) in rats.

28-Day repeated dose oral toxicity study (OECD407) of 2-desoxyparaherquamide (2 DOPH) batch 5789-MAM-9901, in the rat

12-Day repeated dose oral toxicity sighting study of 2 desoxyparaherquamide (PF-520904) batch 5789-MAM-9901, in the Sprague Dawley rat

PNU-141962: 3 day escalating oral dose range-finding toxicity study in rats.2-DOPH sub acute rat toxicity study of various impurity profiles.

04 Mar 2009

May 2006 a,emded 27 Mar 013 Mar 2009

2 Feb 2009

20 Feb 2009

28 Mar 2006

23 Apr 2009

16 Aug 2005

21 Mar 2005

01 Sept 1999

04 Aug 2008

-

-

-

-

-

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant













36693

36692

36691

36704

36705

36706

36707

36721

36720

36719

36718

1471N-60-08-524#3-24

1471N-60-08-521#3-23

1471N-60-08-522#3-22

1462N-60-05-703#3-35

1461N-60-08-845#3-36

06KL031#3-37

1471N-60-07-477 #3-38

4022 #3-52

#3-51

#3-50

07GR277#3-49

Rodabaugh, D.D.

Lloyd, Z.

Lloyd, Z.

Savides, M.C.

May, J.R.

Bonnette, K.L.

Bonnette, K.L.

Neliat, G.

Kenyon, M.O.

Vogel, W.M.

Coffing, S.

An acute toxicity study of PF-00520904/Abamectin (Startect) administered by the nose only inhalation route to rats.

A primary eye irritation study with PF-00520904/ Abamectin (Startect) in rabbits.

A primary skin irritation study with PF-00520904/ Abamectin (Startect) in rabbits.90-Day oral toxicity study in dogs with PF-00520904

3-Month oral toxicity study of PF-00520904 in dogs

A 1-Year Toxicity Study of PF-520904 Administered by Oral Gavage to Rats

A 1-Year Toxicity Study of PF-00520904 Administered by Oral Gavage to Rats

Study of PNU-97333 in various receptor binding assays

DEREK assessment of structural toxicity alerts for PF 00520904 and related compounds, PF-03198957, PF-03768626, PF-04935590

DEREK assessment of structural toxicity alerts for PF-00520904 and related compounds, PF-03198957, PF-03198961, PF-03334456

In vivo liver micronucleus assay of PF-00520904Pfizer study 1470-N-60-07-484

7 Nov 2008

13 Oct 2008

15 Oct 2008

9 Dec 05 Amended 22 Mar 0

19 Feb 2009

20 Feb 2009

16 Feb 2009

08 Dec 1999

06 Feb 2009

01 Nov 2005

24 Mar 2008

-

-

-

-

-

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant













36717

36716

36756

36715

36713

36712

36711

36710

36709

36708

1471N-14-04-299#3-48

3605#3-47

ATM-0374 Issue 4

1471N-14-04-293#3-46

06KL023#3-44

1471N 60 05-328#3-43

1470N-14-05-329#3-42

1471N-14-05-329

1476N-60-07-4383-40

62-100 #3-39

Brook, F.

Mauthe, R.J.

Argenta

Brook, F.

Lewis, E.M.

Lewis, E.M.

Rozinova, E.

Rozinova, E

Barnett, J.F.

Allen, D.G., et.al.

In vivo micronucleus test of 2 Desoxyparaherqu amide (PF-520904, batch 5789-MAM-9901) in the mouse.

In vitro structural chromosome aberration assay of PF-520904 in human peripheral lymphocytesIdentification, Assay and Related Substances ofAbamectin for 2-Desoxyparaherquamide (1% W/V)plus abamectin (0.1% W/V) Oral Liquid for Sheep. With Validation Report

Bacterial reverse mutation assay (OECD 471/VICH GL23) of 2-desoxy paraherquamide (PF-520904, batch 5789-MAM-9901).

Oral (Stomach Tube) Developmental Toxicity Study of PF-520904 in Rabbits

Oral (stomach tube) dosage-range developmental toxicity study of PF- 520904 in rabbits

Prenatal developmental toxicity main study of 2-desoxyparaherqua mide in the rat (OECD414/ VICHGL32).

Prenatal developmental toxicity sighting study of 2-desoxy paraherquamide in the rat (OECD414/ VICHGL32).

Oral (gavage) two-generation (one litter per generation) reproduction study of PF-00520904 in ratsPrediction of rodent carcinogenesis: An evaluation of prechronic liver lesions as forecasters of liver tumors in NTP carcinogenicity studies

02 Feb 2005

10 Nov 2005

June 2009

25 Jan 2005

29 Jun 2007

24 Mar 2006

03 Mar 2006

30 Jan 2006

2 Mar 2009

2004

-

-

-

-

-

-

-

-

-

Tox Pathol 2004;32:393-401

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Public











36714

36690

36757

36759

62575

62574

62573

62572

a0009450#3-45

1471N-60-08-523#3-21

ATM-0375 Issue 4

2-83 to 2-85

Vet par 59 (1995) 139-156

121 (2004) 277-283

Br.Vet.J.(1980),136,88

Vol15, No.3

Mayo, J.

Lloyd, Z.

Argenta

Anon

Wesley L. Shoop, Helmut Mrozik, Michael H. FisherAlka, R.M. Gopal, K.S.Sandhu, P.K. Sidhu

J.R.Egerton, J.Birnbaum, L.S. Blair, J.C. Chabala, J.Conroy, M.H. Fisher, H.Mrozik, D.A.Ostlind, C.A. Wilkins and W.C. Campbell

J.R. Egerton, D.A. Ostlind, L.S.Blair, C.H.Eary, D.Suhayda, S.Cifelli, R.F.Riek and W.C.Campbell

Evaluation of twenty-one compounds from various discovery programs in the non-GLP preincubation mutagenesis assay in bacteria (Ames assay).

A dermal sensitization study with PF-00520904/ Abamectin (Startect) in guinea pigs (modified Buehler).

Identification, Assay and Related Substances of 2-Desoxyparaherquamide (2DOPH) in 2DOPH (1%W/V) plus abamectin (0.1% W/V) Oral Liquid forSheep. With validation report

Batch Analysis of derquantel/abamectin (10.0/1.0 mg/mL) oral solution

Structure and activity of avermectins and milbemycins in animal health.

Efficacy of abamectin against ivermectin-resistant strain of Trichostrongylus colubriformis in sheep

22, 23-Dihydroavermectin B1, A new Broad-Spectrum Antiparasitic Agent

Avermectins, New Family of Potent Anthelmintic Agents: Efficacy of the B1a Component

30 Mar 1998 amended 3 May

26 Nov 2008

June 2009

June 2009

1995

2004

1980

1979

-

-

-

-

Veterinary Parasitology 59 (1995) 139-156Veterinary Parasitology 121 (2004) 277-283

Br.vet.J. (1980), 136, 88

Antimicrobial Agents and Chemotherapy,Mar.1979, Vol 15, No. 3, p. 372-378

Applicant

Applicant

Applicant

Public

Public

Public

Public




-

-

-

-





48899

48898

48897

48896

48895

48894

48893

46142

46141

62576

6447R-14-09-226

6441R-14-09-224

RTQ2010attach1

RTQ2010attach5

RTQ2010attach3

RTQ2010attach2

1/203

#3-76

#3-75

New Zeal 54(1), 47-49

Little P, Hodge A, Krautmann M

Little P, Hodge A, Krautmann M

Anon

Anon

Anon

Anon

Anon

Barlow, S

Reiss, R

J Wrigley, M McArthur, PB McKenna and B Mariadass

Investigation of the field safety of derquantel-abamectin in 9-13 week-old lambs, following a single and a repeat oral dose

Investigation of the toleration and safety of derquantel-abamectin in pre-ruminant lambs, when administered at 1X, 2X and 3X the maximum label dose.

Amended Derquantel Batch Analysis Tables

Updated Drug Product Stability Data

Specifications and Certificdates of Analysis for abamectin sourced from North China Pharmaceutical Group Aino Co., Ltd

Test Method and Validation Report for TA 3268

Certificate of Analysis Avermectin batch 081011

Expert Report on Benchmark Dose Analysis by Exponent

Benchmark Dose Analysis of Rat Toxicity Studies for Derquantel

Resistance to a triple combination of broad-spectrum anthelmintics in naturally-acquired Ostertagia circumcincta infections in sheep.

25 Feb 2010

25 Feb 2010

various

15 Dec 2010

15 Dec 2010

15 Dec 2010

24 Dec 2008

3 March 2010

March 2010

2006

-

-

-

-

-

-

-

-

-

New Zealand Veterinary Journal 54(1), 47-49, 2006

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Public













46140

62577

62579

72303

72302

72301

72300

72299

72298

#3-74

Vol1 March 2012 ,Page 75

Vol 1, March 2012 Page 87

ER-14, Vol 2, Page 754






Pfizer, Sandwich, Kent, UK

N. Mestorino, E. Turic, J. Pesoa, J Echeverria, J.O. Errecalde

Q.A. McKellar, F. Jackson, R.L. Coop, E. Jackson and E. Scott

Dr. Arrie du Plessis, Mrs. Millicent Zondi

ERMA New Zealand

Veterinary Medicines Directorate

Veterinary Medicines DirectorateVeterinary Medicines Directorate


Derquantel Maximum Residue Limits Responses to Questions Part A Safety March 2010. Vol 1 of 7. With appendices

Pharmacokinetics in plasma of ivermectin after its oral (solution and tablets) administration to sheep

Effect of parasitism with Nematodirus battus on the pharmacokinetics of levamisole, ivermectin and netobimin.

Letter Response to questions of 6 September 2010

Evaluation and Review Report Application for Approval to Import Derquantel and Import or Manufacture Derquantel-Abamectin Formulation for Release

Startect Dual Active Oral Solution for Sheep, CONSOLIDATED LIST OF QUESTIONS, DCP RMS CLOQ Phase II Day 30

STARTECT, RMS'S ASSESSMENT OF RESPONSE TO CONSOLIDATED LIST OF QUESTIONS Phase I Day 120STARTECT CONSOLIDATED LIST OF QUESTIONS DCP RMS CLOQ Phase I Day 105

DCP DAY 70 PROVISIONAL ASSESSMENT REPORT No. SP 10893,

March 2010

2003

1991

17 September 2010

18 December 2009

2011

2010

2010

23 July 2010

-

J. vet. Pharmacol. Therap. 26, 307-309, 2003

Veterinary Parasitology. 39 (1991) 123-126 Elsevier Science Publishers B.V. Amsterdam

-

http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/ERMA200037%20E%20and%20R%20Report.pdf

-

-

-

-

Applicant

Public

Public

Applicant

Public

Applicant

Applicant

Applicant

Applicant


-

-


-








72297

72296

72295

72294

65398

63991

62580

62578

36793

36792




ER-1, Vol 1, Page 5

The Safety of Derquantel

Response to Residue repor

Vol 1, March 2012 Page 70

Vol1, March 2012,Page 78

1A73N-03-05-367#7A-25 & 7

IA73N-03-05-335. #7A

Pfizer

Pfizer

Anonymous

J. Schefferlie

Anon

Anon

S.E. Marriner, I. McKinnon & J.A. Bogan

J.A. Bogan, Q.A. McKellar

Hargreaves, T.L.

Hargreaves TL, Murphy CM

APPLICATION EU/09/168/PFZ for the ESTABLISHMENT of MRLs for DERQUANTEL in SHEEP: RESPONSE TO QUESTIONS

APPLICATION EU/09/168/PFZ for the ESTABLISHMENT of MRLs for DERQUANTEL in SHEEP: RESPONSE TO QUESTIONS

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE STATUS REPORT Derquantel, EMEA

Application for the Establishment of MRLs for Derquantel (sheep), Rapporteur's (Co-Rapporteur's) Assessment Report Template Establishment of Maximum Residue Limits (MRLs)

The Safety of Derquantel - Update following discussions at the 20th CCRVDF

Response to the 27 October 2011 Residues AssessmentReport by APVMA for DerquantelThe pharmacokinetics of ivermectin after oral and subcutaneous administration to sheep and horses

The pharmacodynamics of ivermectin in sheep and cattle

Determination of Acute Toxicity (EC50) of 2-desoxoparaherquamide to Musca autumnalis.

2-Desoxoparaherquamide, Determination of Acute Toxicity (EC50) to Daphnia Magna (48 hr static)

15 February 2010

12 March 2010

16 September 2009

16 July 2009

June 2012

April 2012

1987

1988

3 Sep 2007

11 Nov 05

-

-

-

-

-

-

J. Vet Pharmacol. Therap. 10, 175-179, 1987

J.vet.Pharmacol. Therap. 11, 260-268, 1988

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Public

Public

Applicant

Applicant







-







36791

36772

36771

36770

36769

36768

36767

36766

#5B.8-2

#8-79

#8-78

#8-77

#8-76

#8-75

#8-74

#8-73

Japan Food Chemical Research Foundation

Seaman JT, Eagleson JS, Carrigan MJ, Webb RF.

Sargison ND, Stafford KJ, West DM.

Robinson NE.

Prichard RK, Steel JW, Lacey E, Hennessy DR.

Page S, Hennessy D.

O'Brien JJ.

Hennessy DR.

Table of MRLs for Agricultural Chemicals: Abamectin

Avermectin B1 toxicity in a herd of Murray Grey cattle.

The effects of age,weaning, drench volume and yarding on ruminoreticulum bypass in sheep, withreference to the anthelmintic efficacy of benzimidazole drenches.

Chapter 48: Control of Ventilation.

Pharmacokinetics of ivermectin in sheep following intravenous, intra-abomasalor intraruminal administration.

Chapter 73: Pharmacology andTherapeutics.

Toxicological aspects of some modernanthelmintics.

Modifying the formulation or deliverymechanism to increase the activity of anthelmintic compounds.

2009

1987

1998

2002

1985

2007

1970

1997

http://www.m5.ws001.squarestart.ne.jp/foundation/agrdtl.php?a_inq=3900

Australian Veterinary Journal 1987; 64:284-5

New Zealand Veterinary Journal 1998; 46:20-27

Cunningham J, editor. Textbook of Veterinary Physiology. 3rd ed. Philadelphia: WB Saunders Company; 2002. p. 501-505

Journal of Veterinary Pharmacology andTherapeutics 1985; 8:88-91

In: Aitken ID, editor. Diseases of Sheep, 4th ed., Boston:Blackwell Publishing; 2007. p. 544-573.

Australian Veterinary Journal 1970; 46:297-300VeterinaryParasitology 1997; 72:367-390

Public

Public

Public

Public

Public

Public

Public

Public

-

-

-

-

-

-

-

-





36765

36764

36763

36762

36761

36760

36773

36774

36775

#8-72

#8-71

1442N-03-06-172#8-70 & 4-

1442N-03-06-173#8-69 & 4-

2-122 to 2-217

2-86 to 2-121

Protocol 1999-0285#8-80

#8-81

#8-82

Anon

Anon.

Johnston DL

Gibson N.,

Anon

Anon

Seaman WJ.

Shoop WL, Eary CH, Michael BF, Haines HW, and SewardRL.

Shoop W, Haines HW, Eary Ch, Michael BF.

Ovimec Sheep Drench. Dublin, Ireland

Abamectin. PesticideInformation Profiles, Extension Toxicology Network.

Reproductive Safety Study with acombination Abamectin / 2-Desoxoparaherquamide (2-DOPHQ) oral drenchused at 3 X nominal dose rate in male sheep.

Reproductive Safety Study with acombination Abamectin / 2-Desoxoparaherquamide (2-DOPHQ) oral drenchused at 3 X nominal dose rate in female sheep.

Stability Tests On the Medicinal Product

Stability Tests on the Active Substance

Protocol number 1999-0285. 1-Day oral toxicity/toxicokineticstudy in horses using a 2 mg/kg dose.Anthelmintic activity of paraherquamide in dogs.

Acute toxicity ofparaherquamide and its potential as an anthelmintic.

3 June 05

June 1996.

2009

2008

June 2009

June 2009

2000

1991

1992

Cross Vetpharm Group LimitedEXTOXNET bulletin:http://extoxnet.orst.edu/pips/abamecti.htm.

-

-

-

-

-

Veterinary Parasitology1991; 40:339-341

American Journal ofVeterinary Research 1992; 53:2032-2034.

Public

Public

Applicant

Applicant

Applicant

Applicant

Applicant

Public

Public

-

-






-





36776

36790

36789

36788

36787

36786

36785

#8-83

#5B.8-1

1A73N-03-05-370#7B-28

1A73N-03-05-365#7B-27

260E-155#7B-26

#3-73

#3-72

Shoop W, Soll M.

EMEA

MacDonald AMG, Nelson KJ

MacKinnon IMR

Schaefer EC, Siddiqui AI

Eustis, SL, et. al.

Brix, AE., Nyska A, Haseman JK., Sells DM, Jokinen MP andWalker NJ.

Chapter 1.1: Ivermectin, Abamectin, andEprinomectin.

Abamectin (Revision of Acceptable Daily Intake) Summary Report (4)

Terrestrial Plant Growth Test with 2-Desoxoparaherquamide. Charles River Labs Report 27098.

Soil Microorganisms: Nitrogen Transformation Test with 2-Dexoxoparaherquamide. Charles River Labs Report 27169.

PF-520904: Aerobic HA50-Bacterial Toxicity Rangefinder Test,Wildlife International

Liver

Incidences of Selected Lesions in Control Female HarlanSprague-Dawley Rats from Two-Year Studies Performed by the NationalToxicology Program,

2002

2002

2006

2006

2005

1990

2005

Vercruysse J and Rew RS, editors. Macrocyclic Lactones inAntiparasitic Therapy, Cambridge: CAB International 2002. p. 1-29.http://www.emea.europa.eu/pdfs/vet/mrls/083802en.pdf.-

-

-

Boorman GA, Eustis SL, ElwellMR, Montgomery CAJ, MacKenzie WF, eds. Pathology of the Fischer Rat. SanDiego: Academic Press, Inc.; 1990:83 .Toxicologic Pathology, 33:4:477-483

Public

Public

Applicant

Applicant

Public

Public

-

-



-

-





36758

36784

36782

36781

36780

36779

36778

ATM-0376 Issue 1

#3-71

#3-69

#3-68

#3-67

843-7923-1-RMZ-00-002 #8-

#8-85

Argenta

Anon

Anon

Michael B, Yano B, Sellers RS, Perry R, Morton D, Roome N,Johnson JK, Schafer K, Pitsch S.

Sellers R, Morton D, Michael B, Roome N, Johnson JK, YanoBL, Perry R, Schafer K.

Zaya RM.

VICH Steering Committee.

Determination of Butylated hydroxytoluene (BHT) in Oral Sheep Drench Formulations by Reversed-Phase Liquid Chromatography (HPLC). Assay Method. Assay Method and Validation

Enrofloxacin (WHO Food Additives Series 34)ECETOC Technical Report N0.85. Recognition of, anddifferentiation between, Adverse and Non-adverse effects in Toxicology Studies.ISSN-0773-6347-85.

Evaluation of Organ Weights for Rodent andNon-Rodent Toxicity Studies: A Review of Regulatory Guidelines and a Surveyof Current Practices.

Society of Toxicologic Pathology Position Paper: OrganWeight Recommendations for Toxicologic Studies.

Toxicity trial forPNU-141962 in sheep.

VICH Topic GL43 Step 7 Guideline on Target Animal Safety For Veterinary Pharmaceutical Products

June 2009

2009

Dec 2002

2007

2007

2000

2008

-

WHO

European Centre for Ecotoxicology and Toxicology ofChemicals. Brussels,

Toxicologic Pathology. 2007;35:5:742-750

Toxicologic Pathology.2007;35:5:751-755 .

-

VICH web site: http://www.vichsec.org/

Applicant

Public

Public

Public

Public

Applicant

Public


-

-

-

-


-





36777

36783

36689

36688

36687

36599

36598

36597

#8-84

170909j#3-70

1471N-60-08-520#3-20

1471N-60-08-519#3-19

6-164 #3-18

1542N-60-08-197#8-24

#8-22

1241R-14-04-167#8-21

Taylor P,

Anon

Lloyd, Z.

Lloyd, Z.

JECFA database

Walker, A.

Dobson, R.J., et.al.

Chambers, M.

Chapter 9: Agents acting at the neuromuscular junction and autonomic ganglia.

EMEA Committee for Veterinary Medicinal Products.Enrofloxacin Summary Report (1),

Acute dermal toxicity study with PF-00520904/Abamectin (Startect) in rats - limit test.An acute oral toxicity study with PF-00520904/Abamectin (Startect) in rats (up/down design) - limit test.

Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives. Monograph on Butylated Hydroxytoluene.

Definitive Determination following Oral Administration in Sheep, of the interaction between 2-Desoxoparaherqua mide (2-DOPH) and Abamectin (ABA) when dosed in combination, compared with when dosed separately

Principles for the use of macrocyclic lactones to minimise selection for resistanceDetermination of the therapeutic efficacy of PF-520904-00 administered orally to sheep against experimentally induced infection of a range of larval stage intestinal nematode parasites in sheep;

2006

1998

26 Nov 2008

17 Oct 2008

06 Feb 2004

21 May 2009

2001

2005

Hardman JG and Limbird LE, editors.Goodman & Gilman's The Pharmacological Basis of Therapeutics. 11th edition.New York: McGraw-Hill 2006

EMEA

-

-

Database provided by IPCS INCHEM

-

Aust. Vet. J. 79, 756-761

-

Public

Public

Applicant

Applicant

Public

Applicant

Public

Applicant

-

-


-


-






36596

36595

36594

36593

36592

36591

36590

1241R-14-04-166 #8-20

1242N-14-04-160#8-19

1242W-14 -04-163#8-18

7242W-14-04-151#8-17

8B40W-14 -03-152#8-16

843-7923-0-SSJ-003 #8-15

843-7923-0-SSJ-002 #8-14

Chambers, M.

Chambers, M.

Bailey, J.

Chambers, M.

Weatherley, A.J., Maeder, S.

Johnson,S.S. et. al.

Johnson,S.S. et. al.

Determination of the therapeutic efficacy of PF-520904-00 administered orally to sheep against experimentally induced infection of a range of adult stage intestinal nematode parasites in sheep.

Determination of the therapeutic efficacy of PF-520904-00 against liver fluke (Fasciola hepatica) when administered orally to sheep. Artificial Infection and Critical Sacrifice Study.

Confirmation of the therapeutic efficacy of PF-520904-00 administered orally to sheep against a naturally acquired infection with multiple anthelmintic resistant strains of Teladorsagia spp and Trichostrongylus spp, other intestinal parasites and lungworm

Determinatiof the therapeutic efficacy of PF-520904-00 administered orally to sheep against a naturally acquired infection with multiple anthelmintic resistant strains of Teladorsagia spp and Trichostrongylus spp

Determination of the therapeutic efficacy of PF-520904-00 administered orally to sheep against a naturally acquired infection with a multiple anthelmintic resistant strain of Haemonchus contortus

Dose determination study of PNU-141962 Drench against Immature Nematodes in Sheep;

Dose determination study of PNU- 141962 Drench against Adult Nematodes in Sheep;

2005

2004

2005

2005

2004

2000

2000

-

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant












36589

36588

36587

36600

36586

36601

36603

#8-13

#8-12

#8-11

6241R-14-05-160#8-27

#8-9

6242C-14-07-179#8-28

6242C-35-07-173#8-30

Leathwick, D.M., et.al.

Woodgate, R.G., et.al.

Robertson, A.P.

Chambers, M.

Johnson, S.S. et.al.

Chambers, M.

van Schalkwyk, P.C.,

Ivermectin-resistant Ostertagia circumcincta from sheep in the lower North Island and their susceptibility to other macrocyclic lactone anthelmintics.

Efficacy of different macrocyclic lactone formulations against macrocyclic lactone resistant strains of Ostertagia In Western Australia.

Paraherquamide and 2-paraherquamide distinguish cholinergic receptor subtypes in Ascaris muscle

Determination of the anthelmintic efficacy of two formulations of 2-desoxyparaher quamide combined with abamectin against gastro-intestinal nematodes in sheep - SUSCEPTIBLE STRAINS

Interrelationships among physiochemical properties, absorption and anthelmintic activities of 2-desoxoparaherquamide and selected analogs.

Determination of the therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against the adult stages of a naturally acquired mixed infection of gastrointestinal nematode parasites;

Therapeutic efficacy of a combination of 2-desoxoparaherqua mide (Code: PF520904-00) and abamectin administered orally to sheep against the adult stages of a naturally acquired mixed infection of gastrointestinal nematode parasites

2000

2001

2002

2006

2004

2007

2007

N.Z. Vet. J. 48, 151-154.

Proceedings of the Australian Sheep Veterinary Society Conference 11, 29-31J. Pharmacol. Exp. Ther. 302, 853-860.

-

J. Vet. Pharmacol. Therap. 27, 169-181

-

-

Public

Public

Public

Applicant

Public

Applicant

Applicant

-

-

-


-







36616

36615

36614

36613

36612

36611

6241C-14-06-170 #8-43

6241C-14-07-188#8-42

6243C-14-06-168 #8-41

6214R-14-05-162#8-40

#8-39

5241C-03-07-176#8-38

Chambers, M

Knox, M.

Chambers, M.

Chambers, M.

Benz, G.W.,et.al.

Lester, H.E.

Therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against anthelmintic resistant strains of three gastrointestinal nematode parasites

Therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against anthelmintic resistant strains of three gastrointestinal nematode parasites

Field safety and efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against a naturally acquired mixed infection of gastrointestinal nematode parasites

Determination of the anthelmintic efficacy of two formulations of 2-desoxyparaher quamide combined with abamectin against gastrointestinal nematodes in sheep - RESISTANT STRAINS

Use of ivermectin in cattle, sheep, goats and swine.

Anthelmintic Dose Confirmation for a Combination of PF 520904-00 and Abamectin in an Oral Drench Administered to Worm Free Sheep Artificially Infected with L4 Larval Stages of Cooperia curticei and Trichostrongylus axei.

2007

2007

2007

2006

1989

2009

-

-

-

-

Campbell, W.C. (Ed.), Ivermectin and Abamectin. Springer-Verlag, New York, pp. 215-229.

-

Applicant

Applicant

Applicant

Applicant

Public

Applicant





-






36610

36609

36608

36607

36606

36605

5241C-03-06-168#8-37

6241C-45-07-184#8-36

6241C-14-06-165#8-35

5241C-03-07-175#8-34

5241C-03-07-174 #8-32

5241C-03-07-174 #8-32

Lester, H.E.

Lind, J

Chambers, M.,

Lester, H.E.,

Lester, H.E.,

Lester, H.E.,

Anthelmintic Dose Confirmation for a Combination of PF 520904-00 and Abamectin in an Oral Drench Administered to Worm Na‹ve Sheep Harbouring Larval Stages of Anthelmintic Susceptible Nematodes

Therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin, administered orally to sheep, against the L4 larval stages of several gastrointestinal nematode parasites, following artificial infection

Determination of the therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against the L4 larval stages of an artificially induced infection of six gastrointestinal nematode parasites;

Anthelmintic Dose Confirmation for a Combination of PF 520904-00 and Abamectin in an Oral Drench Administered to Sheep Harbouring Haemonchus contortus and Cooperia oncophora Adult Worms

Anthelmintic dose confirmation for a combination of PF 520904-00 and abamectin in an oral drench administered to sheep harbouring naturally acquired Nematodirus battus infections;

Anthelmintic dose confirmation for a combination of PF 520904-00 and abamectin in an oral drench administered to sheep harbouring naturally acquired Nematodirus battus infections;

2008

2007

2007

2009

2008

2008

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant











36604

36602

36585

36584

36583

36564

36563

36562

36561

6242C-35-07-193#8-31

6242C-45-06-166#8-29

#8-8

#8-7

#8-6

ASAE D384#7A-16 & 7B-20

Primefact 523#7A-15 & 7B-

1545N-60-05-171#7A-6 &7B-

JVPT 2002#7A-13 & 7B-16,

Louw, J.P.,

Timms, B.

Mauragis, M.A.,et.al.

Lee, B.H.,et.al.

Lee, B.H.,et.al.

American Society of Agricultural Engineers.

Duddy G, et. al.

Byrd JW. Beauchemin V.

Zinser WE, et al

Therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against the adult stages of a naturally acquired mixed infection of gastrointestinal nematode parasites;

Therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against the adult stages of a naturally acquired mixed infection of gastrointestinal nematode parasites

Process development and preparation of 2-deoxyparaherquamide; implementation of a selective reduction of secondary amides on a kilogram scale.

Marcfortine and paraherquamide class of anthelmintics: discovery of PNU-141962.Semi-Synthesis of 2-desoxo-and 3- epi-paraherquamide A.Manure production and characteristics

Feedlotting lambs..

Generation and TRR determination of ovine excreta and tissue samples containing [14 C]-PF-00520904 residues.

Anthelmintic paraherquamides are cholinergic antagonists in gastrointestinal nematodes and mammals.

2008

2007

2002

2002

2001

2000

Nov 2007

Aug 2008

2002

-

-

Org. Process. Res. Dev. 6, 192-196

Curr. Topics Med. Chem. 2, 779-793Bioorg. Med. Chem. Lett. 11, 553-554ASAE D384.1 DEC99. American Society of Agricultural Engineers

NSW Department of Primary Industries.

-

Journal of Veterinary Pharmacology and Therapeutics. 25:241-250.

Applicant

Applicant

Public

Public

Public

Public

Public

Applicant

Public



-

-

-

-

-


-





36560

36559

36558

36557

36554

36552

36551

36550

36549

IA71N-03-05-320 Report No

List 99, 20087A-12 &7B-14

CAS 187865-22-1 #7A-4 &7B

EMEA/CVMP?ERA/418282/2005

22Jan09#7A-8 &7B-9

1A73N-03-06-396#7A-24 & 7

1A73N-03-05-366.#7A-2 & 7

IA73N-03-05-369. #7A-21 &

IA73N-03-05-368 #7A-22 &

McDonald, E

WHO

Sci-Finder

CVMP

Greening, R.C., Smolenski, W.J.

Taylor, K.

Hargreaves, T.L., Doig, C.J.A.

Knight, B.

Knight B

Laboratory Study of Physical, Chemical and Technical Properties of 2-Des oxoparaherquamide

International non-proprietary names for pharmaceutical substances (INN): Derquantel.

2-desoxoparaherqua mide. American Chemical Society.

Revised Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38

Rationale for the need not to conduct combination ecotoxicity tests with derquantel and abamectin for STARTECT© Pfizer Animal Health Technical Memo

Evaluation of the effect of 2-desoxo paraherquamide on the dung beetle Onthophagus taurus

Earthworm Reproduction Test with 2-Desoxopara herquamide.

Determination of Acute Toxicity (EC50) of 2-Desoxo paraherquamide to Algae (72 hr)

Determination of Acute Toxicity (LC50) of 2-desoxo-paraherquamide to Rainbow Trout (96 H, Static).

5 Jan 2006

2008

2006

17 Nov 2007

22 Jan 2009

19 Dec 2007

3 Sep 2007

28 Sep 2006

28 Sep 2006

-

http://www.who.int/medicines/publications/druginformation/issues/INN-PList-No9 9.pdf

https://scifinder.cas.org/scifinder

http://www.emea.europa.eu/index/indexv1.htm

-

-

-

-

-

Applicant

Public

Public

Public

Applicant

Applicant

Applicant

Applicant

Applicant


-

-

-









36565

36566

36567

36568

36582

36581

36580

36579

36578

36577

2000#7A-17 &7B-21

1A71N-03-05-371#7A-3 & 7B

1A72N-03-05-373#7A-5 & 7B

1981#7A-18 * 7B-24

#8-5

#8-4

#8-3

#8-2

#8-1

2009 #5-9

Smith KA, Frost, JP.

Morriss, AWJ.

Morriss AWJ.

McCall PJ, et.al.

Gill, J.H., Lacey, E.,

Shoop, W.L., et.al.

Blanchflower, S.E.,et.al.Ostlind, D.A.,et.al

Yamazaki, M., et.al

Bryson, WL

Nitrogen excretion by farm livestock with respect to land spreading requirements and controlling nitrogen losses to ground and surface waters. Part 1: cattle and sheep.

The Degradation of [14C]-2-Desoxopara herquamide in Soil Under Aerobic Conditions.

Adsorption/ Desorption of [14C]-2-Desoxoparaherqua mide to Soil.

Measurement of sorption coefficients of organic chemicals and their use, in environmental fate analysis.In vitro activity of paraherquamide against the free-living stages of Haemonchus contortus, Trichostrongylus colubriformis and Ostertagia circumcincta

Anthelmintic activity of paraherquamide in sheep.New paraherquamide antibiotics with anthelmintic activity.Efficacy of paraherquamide against immature Trichostrongylus colubriformis in the gerbil (Meriones unguiculatus)The structure of paraherquamide, a toxic metabolite from Penicillium paraherquei.Withdrawal Time Calculations for Abamectin and Derquantel in Sheep Tissues

2000

31 Jul 2007

23 Jul 2007

1981

1993

1990

1991

1990

1981

2009

Bioresource Technology, 71:173-181..

-

-

Proceedings of AO Symposium, AOAC, Washington DCInt. J. Parasitol. 23, 375-381

J. Parasitol. 76, 349-351J. Antibiot. 44, 492-497Res. Vet. Sci. 48, 260-261.

Tetrahedron Lett. 22, 135-136.-

Public

Applicant

Applicant

Public

Public

Public

Public

Public

Public

Applicant

-



-

-

-

-

-

-






36617

36576

36574

36573

36572

36571

36570

36569

6241C-45-07-185 #8-44

1547R-60-08-201 #5-7

1547N-14-06-181 #5-5

1541N-14-07-184 #5-4

1545N-60-07-186#5-3 & 4-2

1545N-60-05-171#5-2 & 4-2

1545R-60-05-169#5-1 & 4-2

1980#7A-19 & 7B-25

Lind, J.

Guyton, M.

Carnevale J.

Chambers, M et a

Byrd J, BeaucheminV

Byrd J, BeaucheminV

Byrd J, BeaucheminV

Kenaga EE.

Therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against anthelmintic resistant strains of several gastrointestinal nematode parasites.

Validation for the Analysis of PF-00520904 (2-DOPH) in Ovine Liver, Muscle, Kidney, and Fat using UPLC-MS/MS.

Validation of the analytical methodology for the quantitation of Avermectin B1a and Avermectin B1b in ovine tissue.

Pivotal study for the determination of the PF-00520904 (2-DOPH) and abamectin tissue residue profile in sheep following oral administration of the final formulation at 3 mg 2-DOPH/kg and 0.3 mg abamectin/ kg body weight.

PF-00520904 sheep tissue residues for marker ratio confirmation.

Pivotal total residue depletion study in sheep: Generation and TRR determination of ovine excreta and tissue samples containing [14C] PF-520904 residues.

Pilot total residue depletion study in sheep: Generation and TRR determination of ovine excreta and tissue samples containing [14C] PF-520904 residues

Predicted bioconcentration factors and soil sorption coefficients of pesticides and other chemicals.

2008

2009

2008

2009

2008

2008

2006

1980

-

-

-

-

-

-

-

Ecotoxicology and Environmental Safety 4:26-28

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Public







-





36575

36618

36619

36620

36668

36667

36666

36665

1547N-14-06-178 #5-6

6241C-45-07-185 #8-44

6241C-35-07-192#8-46

5241C-03-06-169#8-47

1547R-60-06-176#4-47

6540R-14-05-161#4-46

1547R-60-06-177#4-45

1540R-14-05-168#4-44

Carnevale J.

Lind, J.

van Schalkwyk, P.C.

Lester, H.E.

Zhou, G.

Halloway C, Hennessy, D.

Lu, T-S.

Hennessy, D.

Validation of the analytical methodology for the quantitation of 2-Desoxyparaherquamide in ovine tissue.

Therapeutic efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against anthelmintic resistant strains of several gastrointestinal nematode parasites.

Therapeutic efficacy of a combined formulation of 2-des oxoparaherquamide (Code: PF520904-00) and abamectin administered orally to sheep against anthelmintic resistant strains of Haemonchus contortus and Teladorsagia circumcincta;

Anthelmintic Dose Confirmation for a Combination of PF 520904-00 and Abamectin in an Oral Drench Administered to Sheep Harbouring Anthelmintic Resistant Nematodes;

Method Validation of an LC-MS/MS Assay for the Determination of Abamectin in Sheep Plasma

Validation of the Analytical Methodology for the Quantitation of Avermectin B1A in Ovine Plasma

Validation of an LC-MS/MS Method for the Determination of PF-520904 (2-Desoxoparaherquamide) in Sheep Plasma

Validation of the Analytical Methodology for the Quantitation of 2-Desoxyparaherquamide in Ovine Plasma

2008

2008

2008

2008

14 Dec 2007

12 Mar 2009

14 Nov 2007

27 Jun 2005

-

-

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant













36664

36663

36662

36661

36660

36659

36658

36657

1570R-60-06-402#4-43

1577R-60-08-588#4-42

1570R-60-06-403#4-41

PFPR1666 #4-40

1860N-60-05-734#4-39

1560R-14-05-713#4-38

1442N-03-07-190#8-68 & 4-

1442N-03-06-174#8-67 & 4-

Lu, T-S.

Feenstra, K.

Lu, T-S.

Hennessy, D.

Lu, T-S.

Hennessy, D.

Walker, A.

Walker, A.

Validation of an LC-MS/MS Method for the Determination of PF-520904 (2-Desoxoparaherquamide) in Rabbit Plasma

Partial Validation of an Analytical Method for the Determination of Abamectin and PF-00520904 in Rat Plasma

Validation of an LC-MS/MS Method for the Determination of PF-520904 (2-Desox oparaherquamide) in Rat PlasmaValidation of the Analytical Methodology for the Quantitation of 2-Desoxyparaherquamide in Rat Plasma

Method Validation of an LC-MS/MS Assay for the Determination of PF-520904 (2-Desoxoparaherquamide) in Canine Plasma

Validation of the Analytical Methodology for the Quantitation of 2-Desoxyparaherquamide in Canine Plasma

A Target Animal Safety Study in Sheep Following Oral Administration of a Novel Combination Product Containing 2-Desoxoparaherquamide (2-DOPHQ) and Abamectin

A Target Animal Safety Study in Sheep Following Oral Administration of a Novel Combination Product Containing 2-Desoxo paraherquamide (2-DOPHQ) and Abamectin

15 Feb 2007

23 Oct 2008

24 Jan 2007

Jul, 2005

31 Mar 2006

18 Nov 2006

15 May 2009

08 May 2009

-

-

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant












36656

36669

36670

36671

36672

36686

36685

36684

36683

1997 #4-33

1547R-60-07-192#4-48

7219-96-002 #3-11471N-14-04-298 #3-2

1471N-14-04-297#3-3

6-160 #3-17

6-156 #3-16

6-151 #3-15

6-146 #3-14

Herdt, T.

McDougall, J.

Frank, R.K.,et.al.

Brook, F.

Brook, F.

Kibbe, A.H.

Bonnema, K.J.

Bonnema, K.J.

Bonnema, K.J.

Digestion: the fermentative processes

Transfer of an Analytical Method for the Determination of Abamectin and PF-00520904 in Sheep PlasmaOral single-dose acute toxicity comparison study in Crl:CF-1 BR miceAcute oral toxicity sighting study of 2-desoxyparaherqu amide (PF-520904, Batch 5789-MAM-9901) in the rat

Acute oral toxicity study (OECD401) of 2-desoxyparaherqu amide (PF-520904), batch 5789-MAM-9901, in the rat.Butylated Hydroxytoluene

Safety assessment of propylene glycol dicaprylocaprate as an excipient for a proposed PF-520,904 and abamectin formulation

Safety assessment of glycerol formal as an excipient for a proposed PF-520,904 and abamectin formulation

Safety assessment of triacetin as an excipient for a proposed PF-520,904 and abamectin formulation

1997

26 Aug 2008

16 Jan 1996

24 Nov 2004

25 Jan 2005

2000

22 Aug 2005

18 Jan 2006

18 Jul 2005

In: Cunningham J.G., editor, Textbook of Veterinary Physiology 2nd edit. W.B. Saunders Philadelphia 1997

-

-

-

-

Handbook of Pharmaceutical Excipients, 3rd ed. Washington, DC: American Pharmaceutical Association, 2000: 51-2

-

-

-

Public

Applicant

Applicant

Applicant

Public

-








36682

36681

36655

36680

36678

36677

36676

36675

36674

36673

36679

WIL-558002 #3-13WIL-558001#3-1226 April 2007#4-32

1471N-14-04-295#3-11

1471N-14-04-296#3-9

1471N-14-04-300#3-8

a0066157#3-7

a0058175#3-6

1461R-60-08-847#3-5

7219 96-016#3-41471N-14-04-294#3-10

Kirkpatrick, D.T.

Hurley, J.M.

Anon

Brook, F.

Brook, F.

Brook, F

Seaman, W.J.

Seaman, W.J.

May, J.R.

Frank, R.K.et.al.

Brook, F.

Acute nose-only inhalation toxicity study of PF-520904 in albino rats.Acute eye irritation study of PF-520904 in albino rabbitsIrish Medicines Board Act 1995, European Communities (Animal Remedies) Regulations 2007 (S. I. No. 144 of 2007). VPA: 10915/009/001

Acute dermal irritation/corrosion of 2-desoxyparaherqu amide in the rabbit (OECD404).

Acute dermal toxicity study of 2-desoxy paraherquamide (PF- 520904, batch 5789-MAM-9901) in the rat (OECD402).Acute dermal toxicity sighting study of 2-desoxyparaherqu amide (PF-520904, Batch 5789-MAM-9901) in the rat

PNU-141962: 1-Day oral toxicity/ toxicokinetics study in horses using a 2 mg/kg dose.

PNU-141962: 1-Day oral toxicity study in horses.

U-141962: Preliminary escalating oral dose toxicity study in beagle dogs

Oral single-dose acute toxicity comparison study in Crl:CF-1 BR miceSkin sensitisation study (OECD 406) (guinea pig maximisation test) of desoxyparaherquamide in the Dunkin Hartley guinea pig.

01 Dec 2005

18 Oct 2005

26 April 2007

24 Nov 2004

25 Jan 2005

24 Nov 2004

21 Apr 2000

21 Feb 2000

10 Dec 2008

01 May 1996

25 Jan 2005

-

-

Irish Medicines Board Act 1995, European Communities (Animal Remedies) Regulations 2007 (S. I. No. 144 of 2007). VPA: 10915/009/001.-

-

-

-

-

-

-

-

Public

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

-











72304

36654

36652

36633

36632

36631

36630


#4-31

1542N-60-08-200#4-29

6243C-45-07-177#8-60

6243C-45-07-187#8-59

6243C-45-06-169#8-58

6243C-14-07-189#8-57


Hongbo, H. et al

Walker, A.

Lind, J.

Robinson, D.

Lind, J.

Woodgate, R.

Outstanding concerns regarding a potentially serious risk to human or animal health or for the environment, which if unresolved, would initiate a referral to CMD(V) and possible arbitration.

The Pharmacokinetics of Avermectin B1 after Oral Administration to Sheep and Rabbits

Pharmacokinetics and Bioavailability of 2 Desoxoparaherquamide (2-DOPH) and Abamectin (ABA) in Sheep

Field safety and efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against naturally acquired mixed infection of gastrointestinal nematode parasites



Field safety and efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against a naturally acquired mixed infection of gastrointestinal nematode parasites;

8 November 2011

1998

27 May 2009

2007

2007

2007

2008

-

Acta Veterinaria et Zootechnica Sinica.1998, 29(6), 469-473

-

-

-

-

-

Applicant

Public

Applicant

Applicant

Applicant

Applicant

Applicant


-










36629

36628

36627

36626

36625

36624

6243C-14-07-182#8-56

6243C-14-07-183#8-55

6243C-14-07-181#8-54

6243C-14-07 190#8-53

6243C-14-07-180#8-52

6243C-14-06-168#8-51

Besier (Brown), R.B.

Larsen, J.

Shephard, R.

Dawson, K.

Williams, D.

Chambers, M.




Field safety and efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to sheep against a naturally acquired mixed infection of gastrointestinal and respiratory nematode parasites



2007

2007

2007

2008

2007

2007

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant











36623

36622

36621

36634

36635

36636

36637

#8-50

#8-49

#8-48

6243C-45-07-178#8-61

6243C-45-07-186#8-62

6243C-35-07-172#8-63

6243C-35-06-171#8-64

Mottier, M. de L., Prichard, R.K.

Neveu, C.,et.al.

Van Wyk, J.A., et.al.

Lind, J.

Robinson, D.

Louw, J.P.

Louw, J.P.

Genetic analysis of a relationship between macrocyclic lactone and benzimidazole anthelmintic selection on Haemonchus contortus

Identification of levamisole resistance markers in the parasitic nematode Haemonchus contortus using a cDNA-AFLP approach.

The problem of escalating resistance of Haemonchus contortus to the modern anthelmintics in South Africa.



Field safety and efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to Dorper sheep against a naturally acquired mixed infection of gastrointestinal nematode parasites

Field safety and efficacy of a combined formulation of PF 520904-00 and abamectin administered orally to Merino sheep against a naturally acquired mixed infection of gastrointestinal nematode parasites

2008

2007

1989

2007

2007

2008

2008

Pharmacogenetics and Genomics, 18, 129-140

Parasitology, 134, 1105-1110.

Onderstepoort J. Vet. Res. 56, 41-49

-

-

-

-

Public

Public

Public

Applicant

Applicant

Applicant

Applicant

-

-

-









36651

36650

36649

36648

36647

36646

36653

36645

36643

36642

6540R-14-05-161#4-28

1542R-60-07-183#4-27

843-7926-I-SM-99-001#4-26

843-7926-I-YCA-99-001#4-2

1575R-60-06-408#4-24

1572W-60-06-421#4-20

1542N-60-08-197#4-30

1471N-14-05-319#4-19

1570W-60-04-304#4-41576N-60-05-362#4-3

Hennessy, D.

McLellan, G.

Phipps, A

Arnold, T. et al

Liu, D.

Yancey, M.

Walker, A.

Brook, F.

Marsh, S.

Ma, J.

Definition of the Pharmacokinetic Behaviour of 2-DOPH (PF-520904) and Abamectin in Sheep After Administration of Two Combination PF520904 and Abamectin Oral Formulations

Intravenous Pharmacokinetics of Abamectin (ABA) in Sheep Formulation Evaluation

Pharmacokinetics of PNU-141,962 in Sheep Following Intravenous, Oral or Sub-Cutaneous Administration at 5 mg/kg

Preliminary Pharmacokinetics of PNU-141,962 in Sheep Following Intravenous, Subcutaneous, and Oral Administration to Sheep.

Isolation and Identification of [14C] PF 00520904 Metabolites from Sheep and RatsPreliminary Pharmacokinetic Study of Abamectin in Rats

Definitive Determination, Following Oral Administration in Sheep, of the Interaction Between 2 Desoxoparaherquamide (2-DOPH) and Abamectin (ABA) when Dosed in Combination, Compared with when Dosed Separately.

Acute Oral Pharmacokinetic Study of 2 Desoxyparaherquamide in the Sprague Dawley RatExcretion and Metabolism of [14C] PNU-141962 ([14C] PF-00520904) in RatsIn Vitro Metabolism of [14C] 2-Desoxoparaherquamide in Rat, Sheep, Dog and Human Hepatocytes

May 2006

17 Aug 2007

23 Sept 2003

05 Sept 2000

24 Mar 2009

18 Jan 2007

21 May 2009

10 May 2006

25 Jan 2006

17 Jan 2006

-

-

-

-

-

-

-

-

-

-

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant

Applicant











36641

36640

36639

36638

36644

72305

1576N-60-05-340#4-2

2008#4-1 & 5-10

5241C-03-06-171#8-66

5241C-03-06-170#8-65

1576N-60-06-387#4-5


Ma, J.

Aloysius, H.A., et.al.

Quartly, H.

Quartly, H.

Wu, D.,Liu, D.


In Vitro Metabolism of [14C] 2-Desoxo paraherquamide in Rat, Sheep, Dog and Human Liver Microsomes

Comparative Disposition and Metabolism of Paraherquamide in Sheep, Gerbils and DogsField Safety and Anthelmintic Efficacy of a Combination of PF520904-00 and Abamectin in Sheep

Field Safety and Anthelmintic Efficacy of a Combination of 2-Desoxoparaherquamide and Abamectin in Sheep

Comparative Metabolism Study: [14C] PF 00520904 in Rat Following 7 Daily Oral DosingsPUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Startect Dual Active Oral Solution for Sheep,

04 May 2006

2008

2008

2008

23 Jul 2008

23 November 2011

-

Drug Metabolism and Disposition, 36, 8, 1659-1669.-

-

-

http://www.vmd.defra.gov.uk/ProductInformationDatabase/UKPAR_Documents/UKPAR_361794.doc

Applicant

Public

Applicant

Applicant

Applicant

Public


-




Application Summary for Application No 47910...

Documents

Transcript of Application Summary for Application No 47910...