Oral Dosage Form New Animal Drugs; Ivermectin, Pyrantel, and
Praziquantel Tablets
[Federal Register: November 7, 2006 (Volume 71, Number 215)]
[Rules and Regulations]
[Page 65052]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no06-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Ivermectin, Pyrantel, and
Praziquantel Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an original new animal drug
application (NADA) filed by Virbac AH, Inc. The NADA provides for
veterinary prescription use of chewable tablets in dogs containing
ivermectin, pyrantel pamoate, and praziquantel for the treatment and
control or prevention of various internal parasites.
DATES: This rule is effective November 7, 2006.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, filed NADA 141-257 for IVERHART MAX (ivermectin,
pyrantel pamoate, praziquantel) Chewable Tablets that provides for
veterinary prescription use of chewable tablets in dogs containing
ivermectin, pyrantel pamoate, and praziquantel for the treatment and
control or prevention of various internal parasites. The NADA is
approved as of October 13, 2006, and 21 CFR part 520 is amended by
adding new Sec. 520.1199 to reflect the approval. The basis of
approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this approval
qualifies for 3 years of marketing exclusivity beginning October 13, 2006.
FDA has determined under 21 CFR 25.33 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.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 520
Animal drugs.
? Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
? 1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
? 2. Add Sec. 520.1199 to read as follows:
Sec. 520.1199 Ivermectin, pyrantel, and praziquantel tablets.
(a) Specifications. Each chewable tablet contains:
(1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel
pamoate, and 28.5 mg praziquantel;
(2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg
praziquantel;
(3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg
praziquantel; or
(4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg
praziquantel.
(b) Sponsors. See No. 051311 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer monthly
according to body weight as follows:
(i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this
section.
(ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of
this section.
(iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of
this section.
(iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of
this section.
(v) Greater than 100 lb: use the appropriate combination of tablets.
(2) Indications for use. Prevents canine heartworm disease by
eliminating the tissue stage of heartworm larvae (Dirofilaria immitis)
for 1 month (30 days) after infection and for the treatment and control
of roundworm (Toxocara canis, Toxascaris leonina), hookworm
(Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense)
and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: October 23, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-18684 Filed 11-6-06; 8:45 am]
BILLING CODE 4160-01-S