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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
milbemycin oxime
140-915
Interceptor®
milbemycin oxime
140-915
SafeheartTM
Milbemycin oxime
Milbemycin Oxime Solution
141-163
MILBEMITETM OTIC Solution
Milbemycin Oxime Solution
milbemycin oxime tablets
140-915
INTERCEPTOR®
milbemycin oxime tablets
milbemycin oxime/lufenuron tablets
141-084
SentinelTM Flavor Tablets®
milbemycin oxime/lufenuron tablets

                                                                   
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Summary of 
FDA Information:

Approval Date: September 9, 1996 Freedom of
Information Summary NADA 140-915 I. GENERAL INFORMATION: NADA 140-915 Sponsor: Ciba-Geigy Corporation Animal Health Division Post Office Box 18300 Greensboro, NC 27419-8300 Generic Name: Milbemycin Oxime Tablets Trade Name: INTERCEPTOR ® FLAVOR TABS Marketing Status: Rx, For use by or
on the order of
a licensed veterinarian. Effect of
Supplement: Approval of
this supplemental NADA expands the indications to include the removal and
control of
adult roundworms Toxascaris leonina. Laboratory data support the efficacy of
the drug against this species. Additionally, initial results of
a national prevalence study
showing the prevalence of
this parasite to be 0.74% of
6,458 specimens examined (specimens could have multiple parasites), are contained in this submission. Reference is also made to the clinical field trials originally submitted in support of
the Toxocara canis indications (approved December, 1992).
This supplemental application does not propose any changes in the
formulation, dosage forms, manufacturing procedures, recommended dosages or
monthly treatment regimen for
Interceptor (milbemycin oxime). II. INDICATIONS FOR USE INTERCEPTOR FLAVOR TABS are indicated for
use in the
prevention of
heartworm disease caused by Dirofilaria immitis, the
control of
adult Ancylostoma caninum (hookworm), and

the removal and
control of
adult Toxocara canis and
Toxascaris leonina (roundworms), and

Trichuris vulpis (whipworm) infections in dogs and
in puppies four weeks of
age or
greater and
two pounds of
body weight or
greater. III. DOSAGE FORM(S), ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE The ingredients of
INTERCEPTOR FLAVOR TABS are formulated into
various sized tablets to be administered orally (swallow or
chew), as appropriate for
the weight of
the dog (see below), at monthly dosing intervals.
The tablets supply the recommended minimum dose level of
0.5 mg milbemycin oxime per kilogram (0.23 mg/lb.) of
body weight. Tablet Milbemycin Oxime Dog Weight Per Month Per Tablet ____________ __________ ____________ Up to 10 lbs. 1 2.3 mg 11 to 25 lbs. 1 5.75 mg 26 to 50 lbs. 1 11.5 mg 51 to 100 lbs. 1 23.0 mg Dogs over 100 lbs. are provided the appropriate combination of
these tablets. IV. EFFECTIVENESS A. Dose Establishment No additional dose establishment work was
required.
The minimum target dose of
milbemycin oxime 0.5 mg/kg body weight was
established in the
original NADA 140-915 for
the currently approved label indications. B.Dose Confirmation One dose confirmation study
(Trial AH-93-0045) was
conducted to evaluate the effectiveness of
milbemycin oxime in the
removal and
control of
the adult roundworm, Toxascaris leonina. Twenty-four dogs were
infected with eggs of
Toxascaris leonina by oral inoculation 75-77 days pre-treatment. Twelve dogs were
given a treatment of
0.5 mg/kg minimum dose of
milbemycin oxime one time and
12 were
untreated. All dogs were
necropsied 7 days post-treatment, and

all intestinal parasites were
recovered, identified and
counted. Study Site: CHK-R&D 17190 Polk Road Stanwood, MI 49346 Study Director: Dwight D. Bowman, Ph.D. Animals: 21.5 to 27 week old Beagle dogs 13 males and
11 females 5.3 to 10.6 kg Results: One adult worm was
recovered from
the 12 treated dogs compared to 159 worms from
the 12 untreated control dogs.
The milbemycin oxime treatment was
calculated to be 99.4% efficacious. Conclusion: This study
demonstrated the efficacy of
Interceptor Flavor Tabs against T. leonina. C. 1989 Clinical Field Trial A clinical field trial (MT-147-00-89) was
conducted during 1989-90 to evaluate the safety and
efficacy of
monthly administration of
milbemycin oxime for
the additional indications of
removal and
control of
roundworms and
whipworms when
used under
typical veterinary conditions. Safety and
efficacy data from
animals infected with roundworms was
extracted to support the label change for
this supplement to the NADA. In this study
, 100% (62 of
62) of
the roundworm cases were
successfully treated by study
completion (See Table 1). (Eds note: The following table consists of
4 columns.) TABLE 1 : Effects of
Milbemycin Oxime on Removal and
Control of
Adult Roundworm Infections in Dogs During Clinical Field Trials. Investigator/ Treatment No. of
Dogs Roundworm Location Completing Study Infections _________________________________________________________________________ Legg/ Milbemycin 15 5/5 Texas Filaribits Plus 14 3/3 Stocks/ Milbemycin 9 9/9 California Filaribits Plus 8 8/8 Utgard/ Milbemycin 62 48/48 Florida Filaribits Plus 63 56/55 Totals Milbemycin 86 62/62 = 100% Filaribits 85 67/66 = 98% _________________________________________________________________________ 2 - "Cured" means no eggs found at final fecal examination. D. Prevalence Study National Prevalence of
Canine Parasites based on Centrifugal Sucrose Flotation Examinations of
Fecal Specimens, B. L. Blagburn, D. S. Lindsay, J. L. Vaughan, R. C. Lynn, W. J. Kelch, G. C. Ritchie, D. I. Hepler, July 6-10, 1995, Joint Meeting of
the American Association of
Veterinary Parasitologists/American Society of
Parasitologists, Pittsburg, PA. Fecal specimens (6,458 in total) were
collected from
dogs housed in animal shelters and
analyzed by Dr. Byron L. Blagburn, Auburn University.
The animal shelters were
selected from
the largest cities in each state. Fresh fecal specimens, collected individually into
120 ml plastic specimen cups were
examined using the centrifugal sucrose flotation procedure. Specimen cups were
placed in styrofoam shipping boxes containing "cold pack" inserts, and

shipped to Dr. Blagburn's laboratory at Auburn University via overnight courier. Specimens could contain more than one type of
parasite.
Thus, the
percentages presented below indicate the percent of
specimens that contained the particular parasite and
do not add to 100 percent. Parasite % of
Total __________________________________________ Toxocara canis 14.50 Toxascaris leonina 0.74 Ancylostoma caninum 19.20 Uncinaria stenocephala 1.00 Trichuris vulpis 14.30 Capillaria spp. 0.40 Giardia spp. 0.60 Isospora spp. 4.80 Sarcocystis spp. 0.80 Hammondia spp 0.06 Physaloptera spp. 0.05 Diplydium caninum 0.09 Taeniidae 0.60 __________________________________________ Conclusion: Based upon the 99.4% efficacy demonstrated in the
dose confirmation study
, the
100% efficacy in the
MT-147-00-89 Clinical Field Trial (including the probability albeit low that some of
the roundworms may have been Toxascaris leonina cases), this data is adequate to support the expansion of
the roundworm claim. V. ANIMAL SAFETY This supplemental NADA does not require re-evaluation of
target animal safety data submitted in support of
the initial NADA No. 140-915. Please refer to the original Freedom of
Information Summary (NADA 140-915) for
additional information on target animal safety studies. VI. HUMAN SAFETY: Data on human safety, pertaining to consumption of
drug residues in food, were
not required for
approval of this supplemental NADA.
The drug is to be labeled for
use in dogs, which
are non-food animals. VII. AGENCY CONCLUSIONS: The data in support of
this supplemental NADA application complies with the requirements of
Section 512 of
the Act and
Section 514.111 of
the implementing regulations. It demonstrates that Interceptor® Flavor Tabs, when
used under
the labeled conditions of
use, are safe and
effective. According to the Center's supplemental approval policy (21 CFR 514.106), this is a category II change.
This supplement provides for
an additional claim for
the removal and
control of
the adult roundworm, Toxascaris leonina.
This approval relied upon the safety and
effectiveness data in the
parent application and
evaluation of
new efficacy data submitted in the
supplemental application. Under section 512(c)(2)(F)(iii) of
the Federal Food, Drug, and

Cosmetic Act (FFDCA), this approval qualifies for
THREE years of
marketing exclusivity beginning on the date of
approval because the supplemental application contains reports of
new clinical or
field investigations (other than bioequivalence studies) essential to the approval of
the application and
conducted or
sponsored by the applicant.
The three years of
marketing exclusivity applies only to the additional roundworm claim (Toxascaris leonina) for
which the supplemental application was
approved.
This exclusivity period will expire three years from
the date of
the approval letter.
The drug is restricted to use by or
on the order of
a licensed veterinarian because professional expertise is required to determine the existence of
hookworm roundworm and
/or whipworm infection. In addition, professional expertise is required to determine the existence of
heartworm infection, and

then properly treat existing heartworm infection prior to starting treatment with Interceptor ® (milbemycin oxime) Flavor Tabs in a prevention program. VIII. LABELING (Attached) a. Veterinary Package insert b. Client Package insert Copies of
these 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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