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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
Doramectin
141-061
Dectomax® 1% Injectable Solution For Cattle and
Swine
doramectin
141-095
Dectomax® Pour-On
doramectin
doramectin 0.5% pour-on solution
141-095
Dectomax® Pour-On solution
doramectin 0.5% pour-on solution
doramectin 1% injectable solution
141-061
Dectomax® Injectable Solution
doramectin 1% injectable solution
141-061
Dectomex® Injectable Solution
Doramectin 1% injectable solution

                                                                   
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Summary of 
FDA Information:

Approval Date: July 18, 1997 Freedom of
Information Summary NADA141-061 I. GENERAL INFORMATION: NADA 141-061 Sponsor: Sponsor: Pfizer, Inc. 235 East 42nd Street New York, New York 10017 Generic Name: Doramectin 1% injectable solution Trade Name: DECTOMAX® Injectable Solution Marketing Status: Over-the-counter (OTC) Effect of
Supplement: New claims for
persistent control of
gastrointestinal roundworms and
lungworms in cattle II. INDICATIONS FOR USE: For the treatment and
control of
the following nematode and
arthropod parasites in cattle. Gastrointestinal roundworms Ostertagia ostertagi Adults and
fourth-stage larvae Ostertagia ostertagi Inhibited fourth-stage larvae Ostertagia lyrata Adults and
fourth-stage larvae Haemonchus placei Adults and
fourth-stage larvae Trichostrongylus axei Adults and
fourth-stage larvae Trichostrongylus colubriformis Adults and
fourth-stage larvae Trichostrongylus longispicularis Adults Cooperia oncophora Adults and
fourth-stage larvae Cooperia punctata Adults and
fourth-stage larvae Cooperia pectinata Adults Cooperia surnabada (syn.mcmasteri) Adults and
fourth-stage larvae Bunostomum phlebotomum Adults Strongyloides papillosus Adults Oesophagostomum radiatum Adults and
fourth-stage larvae Trichuris spp. Adults Lungworms Dictyocaulus viviparus Adults and
fourth-stage larvae Eyeworms Thelazia spp. Adults Grubs Hypoderma bovis Hypoderma lineatum Lice Haematopinus eurysternus Linognathus vituli Solenopotes capillatus Mange mites Psoroptes bovis Sarcoptes scabiei Dectomax injectable solution has been proved to effectively control infections and
to protect cattle from
reinfection with Ostertagia ostertagi for
21 days, and

Cooperia punctata and
Dictyocaulus viviparus for
28 days after treatment. III. DOSAGE A. DOSAGE FORM DECTOMAX Injectable Solution is a sterile 1% solution containing 10 mg doramectin/mL. B. ROUTE OF ADMINISTRATION DECTOMAX Injectable Solution may be administered by subcutaneous or
intramuscular injection. C. APPROVED DOSAGES: 200 mcg doramectin/kg body weight (1 mL/110 lb body weight) IV. EFFECTIVENESS Data demonstrating the effectiveness of
DECTOMAX Injectable Solution for
previously approved indications are discussed in the
parent NADA 141-061 FOI Summary (approval
date July 30, 1996). Data from
the following dose confirmation trials demonstrate that DECTOMAX Injectable Solution given at the
recommended dosage protects cattle against infection or
reinfection with Cooperia punctata and
Dictyocaulus viviparus for
28 days after treatment.
A . Dose Confirmation Study No. 1231C-60-95-198 1. Type of
study
: Dose confirmation of
persistent efficacy against artificially-induced infections of
nematodes in cattle. 2. Investigator: Dr. Edward G. Johnson Johnson Research Parma, Idaho 3. General design: a. Purpose: To evaluate the persistent efficacy of
doramectin against Dictyocaulus viviparus and
Cooperia punctata. b. Animals: Forty-two (42) Holstein calves (10 per group, with 2 larval viability monitors). Animals were
approximately 3-6 months old and
weighed 75 to 200 kg at the
start of
the study
. All animals were
treated with fenbendazole during the acclimation period to eliminate any existing infections as confirmed by negative fecal egg counts done on Day -1. c. Controls: Control animals received saline. d. Infection: Infective larvae were
given to each animal daily, starting on Day 14 after treatment through Day 28. One thousand Cooperia punctata larvae and
50 Dictyocaulus viviparus larvae were
administered daily.
The larval viability monitors were
administered 2,000 and
30,000 D. viviparus and
C. punctata, respectively on Day 28. e. Dosage form: The dosage form was
the approved formulation of
injectable solution containing 10 mg doramectin per mL. f. Route of
administration: Subcutaneous injection g. Dose: 1 mL/110 lb body weight (200 mcg doramectin/kg body weight) was
given once to each animal in three groups. Groups T1 and
T2 were
treated with saline and
doramectin, respectively, on Day 0. Group T3 was
treated with doramectin on Day 7 and
Group T4 was
treated with doramectin on Day 14. h. Test duration: 42 to 43 days after Groups T1 and
T2 were
treated. i. Pertinent variables measured: Worm counts were
determined at necropsy which
was
42 to 43 days after Groups T1 and
T2 received treatment, 14 to 15 days after the last Cooperia punctata and
Dictyocaulus viviparus larvae were
administered to all groups. 4. Results - The mean worm counts for
each group, number of
infected animals in parentheses, and

percent efficacy are given: D. viviparus C. punctata C. oncophora O. radiatum T1 Saline Control 12 (10) 349 (10) 442 (10) 276 (10) T2 Doramectin 28 days 0 100% 18 (3) 94% 110 (8) 75% 9 (4) 97% T3 Doramectin 21 days 0.1 (1) 99% 0 100% 6 (1) 98% 2 (1) 99% T 4 Doramectin 14 days 0.1 (1) 99% 0 100% 0 100% 0 100% 5. Statistical methods: Nematode percentage efficacies were
calculated using the following formula: [Arithmetic mean number of
nematodes in control cattle) - (Arithmetic mean number of
nematodes in doramectin-treated cattle)] ÷ (Arithmetic mean number of
nematodes in control cattle) x 100 = Percentage Efficacy 6. Conclusion: This study
is adequate to establish a level of
persistent efficacy for
Dictyocaulus viviparus, Cooperia punctata, and

Oesophagostomum radiatum for
28 days and
for
Cooperia oncophora for
21 days. 7. Adverse reactions: Nine animals, representing all treatment groups and
the monitors developed and
were
treated for
pneumonia during the study
. One doramectin-treated animal exhibited salivation at 1 hour post-treatment. Study No. 1231C-60-95-215 1. Type of
study
: Dose confirmation of
persistent efficacy against artificially-induced infections of
nematodes in cattle. 2. Investigator: Dr. Bert Stromberg St. Paul, Minnesota 3. General design: a. Purpose: To evaluate the persistent efficacy of
doramectin against Dictyocaulus viviparus and
Cooperia punctata. b. Animals: Forty-two (42) Simmental and
Simmental-cross calves (10 per group, with 2 larval viability monitors). Animals were
approximately 2-6 months old and
weighed 110 to 200 kg at the
start of
the study
. All animals were
treated with fenbendazole during the acclimation period to eliminate any existing infections as confirmed by negative fecal egg counts done on Day -1. c. Controls: Saline was
administered to the controls. d. Infection: Infective larvae were
given to each animal daily, starting on Day 14 after treatment through Day 28. One thousand Cooperia punctata larvae and
50 Dictyocaulus viviparus larvae were
administered daily.
The larval viability monitors were
administered 2,000 and
30,000 D. viviparus and
C. punctata, respectively on Day 28. e. Dosage form: The dosage form was
the approved formulation of
the injectable solution containing 10 mg doramectin per mL. f. Route of
administration: Subcutaneous injection g. Dose: 1 mL/110 lb body weight (200 mcg ivermectin/kg body weight) was
given once to each animal in three groups. Groups T1 and
T2 were
treated with saline and
doramectin, respectively, on Day 0. Group T3 was
treated with doramectin on Day 7 and
Group T4 was
treated with doramectin on Day 14. h. Test duration: 42 to 45 days after Groups T1 and
T2 were
treated. I. Pertinent variables measured: Worm counts were
determined at necropsy which
was
42 to 45 days after Groups T1 and
T2 received treatment, 14 to 17 days after the last Cooperia punctata and
Dictyocaulus viviparus larvae were
administered to all groups. 4. Results - The mean worm counts for
each group, number of
infected animals in parentheses, and

percent efficacy are given: D. viviparus C. punctata C. pectinata Cooperia spp. T1 Saline Control 12 (9) 815 (10) 85 (8) 1545 (10) T2 Doramectin 28 days 0 100% 25 (2) 97% 5 (1) 94% 60 (7) 96% T3 Doramectin 21 days 0 100% 20 (2) 97% 15 (1) 82% 50 (3) 96% T 4 Doramectin 14 days 0 100% 0 100% 0 100% 10 (2) 99% 5. Statistical methods: Nematode percentage efficacies were
calculated using the following formula: [Arithmetic mean number of
nematodes in non-medicated cattle) - (Arithmetic mean number of
nematodes in doramectin-treated cattle)] ÷ (Arithmetic mean number of
nematodes in non-medicated cattle) x 100 = Percentage Efficacy 6. Conclusion: This study
is adequate to establish a level of
persistent efficacy for
Dictyocaulus viviparus and
Cooperia punctata for
28 days. 7. Adverse reactions: All of
the animals exhibited signs of
pneumonia and
were
treated during the course of
the study
. Study No. 5232E-03-89-027 1. Type of
study
: Dose confirmation of
persistent efficacy against artificially-induced infections of
nematodes in cattle. 2. Investigator: C. Hong, Bsc, PhD Surrey, UK 3. General design: a. Purpose: To evaluate the persistent efficacy of
doramectin against Dictyocaulus viviparus. b. Animals: Forty (40) Fresian-cross calves (10 per group). Animals were
approximately 4-6 months old and
weighed 95 to 141 kg at the
start of
the study
.
The calves were
reared indoors and
had no existing nematode infections as confirmed by negative fecal egg counts done on Day -15. c. Controls: The controls were
nonmedicated. d. Infection: Calves in Groups T1 and
T2 were
administered larvae daily from
Day 0 to Day 28. Calves in Groups T3 and
T4 were
administered larvae daily from
Day 7 to Day 28. One hundred Dictyocaulus viviparus larvae were
administered daily. e. Dosage form: The dosage form was
a prototype of
the commercial formulation of
the injectable solution containing 10 mg doramectin per mL. f. Route of
administration: Subcutaneous injection g. Dose: 1 mL/110 lb body weight (200 mcg ivermectin/kg body weight) was
given once to each animal in two groups. Group T1 was
nonmedicated and
Group T2 was
treated doramectin, on Day 0. Group T3 was
nonmedicated and
Group T4 was
treated with doramectin on Day 7. Group T1 was
the control for
Group T2 and
Group T3 was
the control for
Group T4. h. Test duration: 42 to 43 days after Group T2 was
treated. I. Pertinent variables measured: Worm counts were
determined at necropsy which
was
42 and
43 days after Group T2 received treatment, 14 to 15 days after the last Dictyocaulus viviparus larvae were
administered to all groups. 4. Results - The mean worm counts for
each group, number of
infected animals in parentheses, and

percent efficacy are given: D. viviparus T1 Control 382 (10) T2 Doramectin 28 days 0.4 (2) 99.9% T3 Control 354 (10) T 4 Doramectin 21 days 0 100% 5. Statistical methods: Nematode percentage efficacies were
calculated using the following formula: [Arithmetic mean number of
nematodes in non-medicated cattle) - (Arithmetic mean number of
nematodes in doramectin-treated cattle)] ÷ (Arithmetic mean number of
nematodes in non-medicated cattle) x 100 = Percentage Efficacy 6. Conclusion: This study
is adequate to establish a level of
persistent efficacy for
Dictyocaulus viviparus for
28 days. 7. Adverse reactions: All of
the animals were
given a prophylactic treatment of
Terramycin LA at 1 mL/10 kg on 2 days of
the study
. V. ANIMAL SAFETY As discussed in the
parent NADA 141-061 FOI Summary (approval
date July 30, 1996). VI. HUMAN SAFETY As discussed in the
parent NADA 141-061 FOI Summary (approval
date July 30, 1996). VII. AGENCY CONCLUSIONS The data submitted in support of
this supplemental NADA comply with the requirements of
section 512 of
the Act and
demonstrate that doramectin injectable solution, when
used under
the proposed conditions of
use, is safe and
effective for
controlling infections and
protecting cattle from
reinfection with Cooperia punctata and
Dictyocaulus viviparus for
28 days after treatment. For cattle the tolerance of
residues are specified in 21 CFR 556.225.
The tolerance of
parent doramectin (marker residue) is 100 ppb in liver (target tissue) of
cattle.
The withdrawal time is 35 days following one subcutaneous or
intramuscular injection of
DECTOMAX as specified in 21 CFR 522.770.
The original approval of
doramectin injection was
as an over-the-counter drug. Adequate directions for
use have been written for
the layman, and

the conditions for
use prescribed on the labeling are likely to be followed in practice.
Therefore, the
Center for
Veterinary Medicine (CVM) has concluded that this product shall retain over-the-counter marketing status. Under the Center's supplemental approval policy 21 CFR 514.106(b)(2), this is a Category II change.
The approval of
this change did not require a reevaluation of
the safety or
effectiveness data in the
parent application. Under section 512(c)(2)(F)(iii) of
the FFDCA, this approval for
food producing animals qualifies for
THREE years of
marketing exclusivity beginning on the date of
approval because the supplemental application contains substantial evidence of
the effectiveness of
the drug involved, any studies of
animal safety, or
, in the
case of
food producing animals, human food safety studies (other than bioequivalence or
residue studies) required for
the approval of
the application and
conducted or
sponsored by the applicant.
The three years of
marketing exclusivity applies only to the new claim for
controlling infections and
protecting cattle from
reinfection with Cooperia punctata and
Dictyocaulus viviparus for
28 days after treatment for
which the supplemental application was
approved. VIII. LABELING (Attached) Facsimile bottle label and
package insert for
the 500 mL rubber capped glass vials. Copies of
applicable labels may be obtained by writing to the: Freedom of
Information Office Center for
Veterinary Medicine, FDA 7500 Standish Place Rockville, MD 20855

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