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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
imidocarb dipropionate
141-071
Imizol®
imidocarb dipropionate

                                                                   
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Summary of 
FDA Information:

Approval Date: November 7, 1997 Freedom of
Information Summary NADA 141-071 I. GENERAL INFORMATION: NADA 141-071 Sponsor: Schering-Plough Animal Health 1095 Morris Avenue Union, New Jersey 07083 Generic Name: Imidocarb dipropionate Trade Name: IMIZOLŪ Marketing Status: Rx II. INDICATIONS FOR USE For the treatment of
babesiosis in dogs with clinical signs and
/or demonstrated Babesia organisms in the
blood. III. DOSAGE FORM, FOUTE OF ADMINISTRATION, AND RECOMMEND DOSAGES IMIZOLŪ is a 12% solution of
imidocarb dipropionate. It contains 120 mg of
active imidocarb per milliliter (mL) of
solution. It is available in 10 mL rubber stopper vials and
is intended for
intramuscular or
subcutaneous injection. IMIZOLŪ is to be administered at a rate of
6.6 mg/kg b.w. (3 mg/lb) (i.e. 0.25 mL/10 lb.). Repeat the dose in two weeks for
a total of
two treatments. DOSING GUIDE 6.6 mg/kg b.w. Animal Weight IMIZOLŪ Dosage (mL) 10 lb. (4.5 kg) 0.25 mL 20 lb. (9.1 kg) 0.50 mL 30 lb. (13.6 kg) 0.75 mL 40 lb. (18.2 kg) 1.00 mL 60 lb. (27.3 kg) 1.50 mL 80 lb. (36.4 kg) 2.00 mL 100 lb. (45.5 kg) 2.50 mL IV. EFFECTIVENESS Dose Selection was
based upon the following: a.
The literature and
the field studies support the efficacy of
a dose range from
4 to 10 mg/kg subcutaneously(SC) or
intramuscularly (IM). b. Safety studies have demonstrated safe levels of
Imizol up to 9.9 mg/kg. c.
The dose/dose volume is convenient to calculate based upon the 12% solution (120 mg/mL). Imidocarb dipropionate has been used throughout the world to treat
babesiosis in cattle, sheep, horses and
dogs. Imidocarb dipropionate was
approved in the
United States for
treatment of
babesiosis in horses (NADA 97-288) on September 12, 1978. Babesia in dogs is an intra-erythrocytic parasite and
can be difficult to diagnose. Several presentations of
Babesiosis have been described in dogs.
The most common presentation of
Babesiosis in the
U.S. is the subclinical carrier state. Parasites are rarely seen on blood smears and
clinical signs are inapparent unless the dog is stressed or
put on corticosteroid therapy. Puppies born to carrier bitches may become clinically ill, with a high mortality rate in untreated puppies. Mortality rates can also be high in immunocompromised adults.1 -------------------------------------------------------------------------------- 1 Hoskins, DVM, PhD (Editor).
The Veterinary Clinics of
North America, Small Animal Practice, Tick Transmitted Disease. January 1991:21(1):103-123. -------------------------------------------------------------------------------- Techniques for
diagnosis of
babesiosis include blood smears and
detection of
antibody titers.
A . Dose Determination From 1980 through 1984, ImizolŪ was
evaluated in several dose determination studies (Guelfi 1980, 1981; Euzeby 1981; Awaz 1984). Treatment effects of
ImizolŪ (12% w/v aqueous solution) against Babesia canis in dogs (n=93) were
assessed at dose rates of
0, 1, 2, 3, 4, 5 or
6 mg/kg b.w.
These studies are summarized in Table 1. 1) ImizolŪ 1 mg/kg b.w. Five (5) dogs with natural infections (n=3; Guelfi 1980) or
induced infections (n=2; Euzeby 1981) received 1 mg ImizolŪ/kg b.w. Two dogs with natural infections recovered, but one relapsed a few days after treatment.
The two dogs inoculated with Babesia canis and
treated with a single injection of
ImizolŪ at this dose rate were
not cleared of
the parasites in the
blood, Table 1, page 4 of
this document. 2) ImizolŪ 2 mg/kg b.w. Sixty-seven (67) dogs with natural Babesia canis infections (Guelfi 1980) were
treated with 2 mg ImizolŪ/kg b.w. Fifty-nine dogs recovered rapidly. Poor to fair results were
reported in 8 dogs (relapsed or
not in complete recovery). Two (2) dogs died of
babesiosis and
3 dogs were
not returned by the owners for
evaluation. Rapid recovery was
noted in most dogs. Some dogs relapsed within six months post-treatment (Guelfi 1981). Guelfi (1981) recommended a higher dose rate. 3) ImizolŪ 3 mg/kg b.w. Nine (9) dogs with natural Babesia canis infections were
treated (Guelfi 1980; Euzeby 1981). All dogs recovered rapidly and
there were
no relapses or
deaths. No parasitemia developed in any of
the dogs one month after treatment. One author reported that there were
no relapses at 11 months post-treatment. 4) ImizolŪ 4 or
5 mg/kg b.w.
The treatment effects of
ImizolŪ were
assessed in 8 dogs naturally infected with Babesia canis.
Three dogs received ImizolŪ at a dose rate of
4 mg/kg b.w. (Euzeby 1981), and

5 dogs received 5 mg/kg b.w. (Euzeby 1981, Guelfi 1980) by intramuscular or
subcutaneous injection. All dogs recovered rapidly and
no relapses were
reported. 5) ImizolŪ 6 mg/kg b.w. Nine splenectomized dogs were
inoculated with Babesia canis (Awaz 1984). Four dogs received treatment with 6 mg ImizolŪ /kg b.w. by a single intramuscular injection, 4 dogs received an alternative treatment, and

one dog served as an untreated control. In the ImizolŪ group, 3 dogs recovered in a short time following treatment and
1 dog died. All dogs receiving the alternative treatment recovered.
The dog which
served as the untreated control died of
babesiosis. Note: Guelfi (1980) tested dose rates of
1, 2, 3 and
5 mg ImizolŪ/kg b.w.
A total of
63 dogs treated with an alternative treatment served as controls for
each of
the dose rate comparisons. Table 1. ImizolŪ (12% imidocarb dipropionate) dose determination for
treatment of
Babesia canis. Dose was
established from
the evaluation of
93 dogs treated with ImizolŪ [Internal Mallinckrodt Reports (Guelfi 1980; Guelfi 1981; Euzeby, 1981) and
scientific publications (Awaz 1984)]. Reference No of
Dogs Type of
Infections Therapy & Dose Route Recovered Relapse Deaths Comments Guelfi 1980a 3 Natural ImizolŪ sc 2 1 0 One dog relapsed within a few days of
treatment. Euzeby 1981 2 Inoculate 1 mg/kg b.w. im 0 2 0 Dogs received a single treatment within 24 hours of
inoculation. Some chemo-immunizing properties were
suspected but not definitive. Babesia canis was
present in the
blood of
both dogs. Guelfi 1980a 2 Natural ImizolŪ sc 2 0 0 Rapid recovery. Some parasitemia in young dogs. Guelfi 1980a 65 Natural 2 mg/kg b.w. sc 57 3 2 No data was
available for
3 dogs. Recovery was
rapid in most cases. Fair to poor results were
reported for
3 dogs which
are categorized here as relapses. Two dogs died of
babesiosis.
A higher dose was
recommended. Guelfi 1981 Follow-up of
above cases at six month post-treatment 50 9 1 Nine dogs apparently recovered then relapses occurred 6 months post-treatment. Some owners did not respond to the follow up. One dog died of
babesiosis. Guelfi 1980a 2 Natural ImizolŪ sc 2 0 0 Rapid recovery. Euzeby 1981 7 Natural 3 mg/kg b.w. im 7 0 0 Recovered within 24 hours. No relapses at 11 months Euzeby 1981 3 Natural ImizolŪ 4 mg/kg b.w. im 3 0 0 Recovered within 24 hours. Euzeby 1981 3 Natural ImizolŪ 5 mg/kg b.w. im 3 0 0 Recovered within 24 hours. Guelfi 1980a 2 Natural sc 2 0 0 Rapid recovery. Awaz 1984 4 Inoculate ImizolŪ 6 mg/kg b.w. im 3 0 1 Dogs recovered rapidly and
one dog died shortly after treatment. Dose Determination Literature Cited K. B. Awaz, et al.
Therapeutic Efficacy of
Berenil and
ImizolŪ against Experimental Babesia canis infection in Dogs. Indian J of
Parasitology. 1984; 8(1): 111-112 B. Dose Confirmation: A total of
1,031 dogs (10 were
controls), from
two published reports (Ogunkoya 1981; Bodade 1986) are summarized for
dose confirmation, Table 2. Dogs naturally infected with Babesia canis received a 12% w/v aqueous solution of
ImizolŪ (imidocarb dipropionate) dosed at the
rates of
5 or
6 mg/kg b.w. administered by a single subcutaneous or
intramuscular injection. Ogunkoya (1981) evaluated the effectiveness of
ImizolŪ when
administered at a dose rate of
5 mg/kg b.w. All dogs (n=1,011) received a single subcutaneous injection. Two disease categories are reported here: Group 1 consisted of
808 dogs infected with Babesia canis, and

Group 2 included 203 dogs infected with B. canis and
concurrently infected with other tick- borne parasites. Treatment with ImizolŪ resulted in complete recovery of
763 dogs (94.4%) in Group I, and

159 (78.3%) dogs in Group II. At 3 months post-treatment, 25 dogs (0.03%) in Group I relapsed after an apparent recovery. No data was
provided as to relapses occurring in Group II. No adverse reactions to ImizolŪ treatment were
reported. Bodade (1986) evaluated 20 clinically ill pet dogs of
various breeds and
ages (range 3 months to 7 years). Ten dogs served as untreated controls and
10 dogs received ImizolŪ at a rate of
6 mg/kg b.w. by intramuscular injection. Antibody titers to B. canis were
determined for
both treated and
untreated dogs on a bi-weekly basis for
12 to 24 weeks after treatment. Eight (8) of
the 10 dogs treated with ImizolŪ recovered and
were
still normal 6 months post-treatment with negative antibody titers. Two (2) dogs relapsed 10 weeks after treatment. Four (4) of
the 10 control dogs developed clinical babesiosis and
had to be treated, 2 others exhibited self cures and
the remaining 4 dogs had positive titers and
were
asymptomatic carriers. No adverse reactions to ImizolŪ treatment were
reported. Table 2. Dose confirmation summary.
A total of
1,031 dogs from
two published reports (Ogunkoya, 1981; Bodade, 1986) are summarized. All dogs were
naturally infected with Babesia canis. Dogs received a single injection of
12% w/v aqueous solution of
imidocarb dipropionate dosed at 5 or
6 mg/kg b.w. Reference Treatment No of
Dogs Dose mg/kg b.w. Route Recovered Relapse Deaths Comments Ogunkoya 1981 ImizolŪ 808 5 sc 763 25 0 At 6 weeks post-treatment, 20 dogs had detectable parasitemia but were
not clinically ill. Ogunkoya 1981a ImizolŪ 203 5 sc 159 0 0 Treatment was
reported to be highly effective. No relapse information. Bodade 1986 ImizolŪ 10 6 im 10 2 0 Two dogs relapsed 10 weeks post-treatment; 8 dogs were
normal at 6 months post-treatment and
titers declined until not detectable. Bodade 1986 Control 10 0 0 2 0 0 All dogs with positive titers but not clinically sick. 4 dogs developed babesiosis and
had to be treated, and

6 dogs were
considered carriers. Two dogs were
self cured. a Dogs were
concurrently infected with B. canis and
other hemoparasites. Dose Confirmation Literature Cited P.
A . Bodade, O. O. Oduye. Antibody titers in naturally occurring Babesia canis infections in dogs. Revue D' Elevage Et De medicine Veterinaire Des pays Tropicaux. 1986; 39(2): 185-188.
A . B. Ogunkoya, J.B. Adeyanju and
Y.O. Aliu. Experiences with the use of
ImizolŪ in treating canine blood parasites in Nigeria. J. Small Anim. Pract. 1981; 22: 775-777. C. Field Trials: Clinical effectiveness was
demonstrated in two published papers (Irwin 1991, Adeyanju 1982) and
one clinical trial conducted in the
United States. Results from
these two papers and
the clinical trial are listed in Table 3.
The names of
the investigators in the
clinical trial are listed in Table 4. ImizolŪ was
administered at doses of
4 - 5 mg/kg b.w. or
10 mg/kg b.w. to 325 pet dogs with natural infections of
only Babesia canis or
concurrent infections with other hemoparasites (Table 3, page 9). In one paper (Irwin 1991), 8 puppies (4-9 weeks old) served as controls. All eight puppies died of
babesiosis.
The global distribution of
these field cases involves the United States (n=45), Nigeria (n=265), and

Australia (n=16 + 8 controls). Number of
Dogs Treatment Group 313 4-5 mg/kg imidocarb 12 10 mg/kg imidocarb 1 24 mg/kg imidocarb 8 controls total of
334 dogs; 326 treated/8 controls ImizolŪ was
administered at a dose rate of
4 to 5 mg/kg b.w. by intramuscular or
subcutaneous injection to a total of
313 dogs. Twelve dogs received 10 mg/kg b.w. Complete recovery or
a progressive remission of
clinical signs was
reported in 90% (294/325) of
the cases treated with either 4 to 5 mg/kg or
10 mg/kg of
imidocarb. Some owners did not follow-up; therefore, treatment results were
unknown for
sixteen dogs. Six of
the 325 dogs never exhibited clinical signs, therefore were
not classified as recovered or
relapsed. Two of
the 5 mg/kg b.w. imidocarb-treated dogs relapsed after initial recovery. All eight (8) of
the untreated puppies died. One (1) dog which
received 24 mg/kg b.w. (accidental overdose) died of
ImizolŪ toxicity. Seven (7) dogs died of
babesiosis despite administration of
imidocarb at 4-5 mg/kg b.w. None of
the dogs which
received the 10 mg/kg dose died. Pain at the
time of
injection and
salivation were
frequently reported by veterinarians in the
United States. Other transient adverse effects reported were
nasal drips, vomiting, panting, agitation, and

injection site swelling. Two deaths were
reported to be treatment related and
were
discussed previously (See Table 3). Adeyanju (1982) reported that none of
the dogs treated exhibited adverse reactions. Table 3 Field Trial summary. Dogs naturally infected with B. canis alone or
concurrently with other tick-borne parasitic diseases were
evaluated. Data were
obtained from
two published papers and
one study
report (from a U.S. clinical field trial) which
demonstrates the effectiveness of
ImizolŪ. Reference No of
Dogs ImizolŪ Dose Rate mg/kg b.w. Route Recovered Relapse Death Comments Irwin 1991 8 Controls 0 0 0 8 All were
puppies 4-9 weeks old Irwin 1991 16 5 im 10 No data 4 Four puppies less than 10 weeks old died of
babesiosis; Author did not report on all cases. Adeyanju 1982 260 5 im 249 0 0 95.8% of
the dogs recovered. Progressive remission of
clinical signs and
improvement in hematological values. Parasites were
detected in 10 dogs 6 weeks post-treatment.. Adeyanju 1982a 5 5 im 3 0 2 60% recovered. Progressive remission of
clinical signs and
improvement in hematological values. No parasites in the
blood at 6 weeks post-treatment. Clinical Trial 1996 1 4 im 1 0 0 Dog received a second treatment 14 days after the first. Clinical Trial 1996 31 5 im, sc 25 2 1 a Thirteen dogs received two treatments. Twelve dogs with clinical babesiosis returned to normal. Some owners did not return for
follow-up. One dog with a concurrent hemoparasite infection never improved and
eventually died. Clinical Trial 1996 12 10 im, sc 6 0 0 Six dogs did not exhibit pronounced clinical signs of
Babesiosis. One dog had a concurrent infection of
another hemoparasite and
remained the same. Some owners did not return for
follow up evaluations. Clinical Trial 1996 1 24 im 0 0 1 Dog was
overdosed and
died. a Dogs were
concurrently infected with B. canis and
other hemoparasites. Table 4. List of
field trial investigators who contributed to the U.S. clinical field trial: Steven Bowen, DVM Valley Veterinary Hospital 485 Broadway, Suite F El Centro, CA 92243 619-352-1279 Diane Chesebro, DVM All Animal Clinic 5505 5th Avenue Key West, FL 33040 305-294-5255 Steven Covert, DVM Altamonte Veterinary Hospital 1089 E. Altamonte Drive Altamonte, FL 32701 407-339-1922 Danny Dillon, DVM Kenersville Veterinary Hospital 209-A Century Park Blvd. Kenersville, NC 27284 910-996-3748 Robert Doak, DVM VCA Wyoming Animal Hospital 1300 Wyoming Blvd. N.E. Albuquerque, NM 87112 505-298-7444 Christine Ellis, DVM Arborview Animal Hospital 244 W US Hwy 6 Valparaiso, IN 46383 219-762-7267 Janice Fenichel, DVM ASPCA 424 E. 92nd St. New York, NY 10128 212-876-7700 Joseph Giangarra, DVM Mountain Lore Animal Hospital 765 South End Rd. Southington, CT 06479 860-276-8553 Russell Greene, DVM Phoenix Veterinary Internal Medicine Services 13633 N. Cave Creek Rd. Phoenix, AZ 85022 602-788-2400 Darin Hisanaga, DVM Waipahu Leeward Veterinary Clinic 94-801 Farrington Highway Suite 3 Waipahu, HI 96797 808-671-4095 Gayland Jones, DVM Wabash Valley Animal Hospital 3004 South 7th St. Terre Haute, IN 47802 812-232-5414 Suellen Kotake-Hollars, DVM All Pets Clinic 94-366 Pupupani St. Waipahu, HI 96797 808-671-8424 Vincent LoDuca, DVM Aycock Veterinary Clinic 5490 Stirling Rd. Davie, FL 33314 954-989-8393 William Losch, DVM St. Paul Veterinary Clinic 2620 W. St. Paul Milwaukee, WI 53233 414-342-7800 Louise Morgan, DVM Brewster Veterinary Clinic 56 Underpass Rd. Brewster, MA 02631 508-896-2540 Kerlin Nogle, DVM Aerowood Animal Hospital, P.S., Inc. 2975 156th S.E. Bellevue, WA 98007 206-746-6557 H.J. Rebhan, DVM Waianae Veterinary Clinic 85-794 Farrington Hwy Waiamae, HI 96792 808-696-4161 John Robb, DVM New Fairfield Vet Hospital 36 Route 37 New Fairfield, CT 6812 203-746-3041 G.A. Robertson, DVM Levy Pet Clinic 4242 W. 47th St. North Little Rock, AR 72118 501-758-8550 Joanne Woltmon, DVM Kauai Veterinary Clinic 1864 Haleukana Street Lihue, HI 96766 808-245-4748 Field Trials Literature Cited P. J. Irwin, and

G. W. Hutchinson. Clinical and
pathological findings of
babesia infections in dogs. Australian Veterinary J. 1991; Vol. 68(6):204-209. B. J. Adeyanju, and

Y.O. Aliu. Chemotherapy of
Canine Ehrlichiosis and
Babesiosis with Imidocarb Dipropionate. J of
the AAHA;1982 Sept/Oct, Vol 18:827-830 V. ANIMAL SAFETY A. Toxicity Study Imizol was
administered to four groups of
ten, 9 month-old Beagle dogs at 2.2, 5.5, 7.7 or
9.9 mg/kg b.w. subcutaneously, given twice with two weeks between doses.
A control group (ten similar animals) was
administered saline in an identical manner. ImizolŪ caused pain on injection in nearly all animals, regardless of
dose. One injection site reaction (ulceration of
injection site) occurred at the
highest dose (9.9 mg/kg). Injection site reactions (swelling) after the second injection of
Imizol were
present in 4 out of
the 10 dogs which
received the lowest dose (2.2 mg/kg) and
in all of
the dogs which
received the higher doses of
Imizol.
The dog that developed the injection site ulceration after the first dose of
9.9 mg/kg Imizol also developed injection site ulceration after the second dose of
9.9 mg/kg Imizol. Post-treatment vomiting was
seen in all Imizol-treated groups at a frequency of
1 to 4 out of
10 dogs.
The adverse effect was
not dose related nor did the dogs respond the same to both injections.
These results are consistent with the cholinergic effects attributed to Imizol. On Days 21, 28 and
35 of
the study
there was
a statistically significant increase in serum alanine aminotransferase (ALT, SGPT) and
arginine aminotransferase (AST, SGOT) in the
9.9 mg/kg b.w. as compared to the placebo group. At Day 42, these differences were
no longer apparent. ImizolŪ had no effects, at any dose level, on body temperature, body weight, hematology, other clinical chemistry values or
gross pathology.
This study
demonstrates that the
margin of
safety for
ImizolŪ administered to dogs at 6.6 mg/kg b.w. subcutaneously and
repeated in two weeks is adequate for
its intended use. B. Tolerance Study Imidocarb was
given orally to three groups of
eight, 14 -16 week-old beagle dogs at the
rate of
5, 20, or
80 mg/kg daily for
90 days.
A fourth group of
similar dogs served as untreated controls. In the 80 mg/kg group, all the male dogs(4) died during the trial and
two of
the females were
euthanized in extremis.
Their clinical signs included salivation, diarrhea, anorexia, dyspnea, tachycardia, listlessness and
weakness. Clinical chemistries showed elevations of
serum alanine aminotransferase (ALT, SGPT) and
arginine aminotransferase (AST, SGOT) in the
80 mg/kg treated animals just prior to their death. Post mortem examinations revealed moderate to advanced fatty infiltration in the
livers of
all animals in the
80 mg/kg group. Other findings in this group were
inflammation, thickening and
congestion of
the intestine and
stomach. Histopathology of
those animals that died or
were
killed in extremis revealed hemorrhagic necrosis of
the centrilobular areas of
the liver, vacuolation of
the hepatocytes in the
non-necrotic areas and
proliferation of
the bile duct epithelium. Fat deposition in Henle's loop and
distal convoluted tubules of
the kidney was
noted. In addition, pyknosis and
karyorrhexis of
cells in the
thymus, spleen, lymph nodes, liver and
villi of
the small intestine were
seen. Histopathologic findings of
the two survivors of
this group revealed hepatocyte vacuolation and
esoinophilic hyaline globules in centrilobular hepatocytes, but no other significant findings. In the 20 mg/kg group, all animals had moderate to advanced fatty infiltration of
the liver. Other findings were
inflammation, thickening and
congestion of
the intestine and
stomach. Histopathology revealed three dogs with hepatocyte vacuolation and
two dogs with focal hepatitis.
There were
no changes of
toxicological significance in the
5 mg/kg group as compared to controls.
The target organs of
toxicity were
liver and
intestines in this study
of imidocarb using the oral route of
administration. C. Additional Safety Information: In a pharmacokinetic study
conducted by Abdullah et al (1984), imidocarb was
given to dogs intravenously at a dose of
4 mg/kg. One of
13 dogs died on post-treatment Day 8.
The dog that died had clinical signs characterized by anorexia, listlessness, dypsnea, tachycardia, weakness and
profuse diarrhea.
The target organs of
toxicity in this dog were
lungs and
kidneys, and

some changes were
noted in the
liver and
spleen. Adverse reactions in all thirteen dogs were
salivation and
diarrhea. D. Summary of
toxicity: The toxic syndrome involves lethargy, weakness and
anorexia, with possible signs of
gastrointestinal, liver, kidney and
lung dysfunction. Literature Cited A. S. Abdullah, et al. Adverse Effects of
Imidocarb Dipropionate (ImizolŪ) in a Dog. Veterinary Research Communications. 1984 (8):55-59 VI. HUMAN FOOD SAFETY: Data on human safety, pertaining to consumption of
drug residues in food, were
not required for
approval of this NADA.
The drug is labeled for
use in dogs, which
are non-food animals. VII. AGENCY CONCLUSIONS: The data submitted in support of
this NADA satisfy with the requirements of
Section 512 of
the Federal Food, Drug, and

Cosmetic Act and
Part 514 of
the implementing regulations (Title 21 of
the Code of
Federal Regulations).
The data demonstrate that Imizol (imidocarb dipropionate), when
used under
labeled conditions of
use, is safe and
effective for
the treatment of
babesiosis in dogs. Labeling restricts this drug to use by or
on the order of
a licensed veterinarian because professional expertise and
proper diagnosis are required to determine an infection with Babesia organisms. FDA has determined under
[[section]]25.33 (See 62 FR 40570, 40596, July 29, 1997 to be codified at 21 CFR Part 25) that this action is of
a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental impact statement is required. Under section 512(c)(2)(F)(ii) of
the FFDCA, this approval for
non-food producing animals qualifies for
THREE years of
marketing exclusivity beginning on the date of
approval because the application contains substantial evidence of
the effectiveness of
the drug involved, or
studies of
animal safety required for
the approval of
the application and
conducted or
sponsored by the applicant. VIII. LABELING (Attached) Package insert Vial Carton Display Carton 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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