Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel, 16270 [E7-6181]
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16270
Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Rules and Regulations
Commission, Three Lafayette Centre,
1155 21st Street, NW., Washington, DC
20581. Requests for public records
directed to a regional office of the
Commission pursuant to § 145.2 should
be sent to:
Commodity Futures Trading
Commission, 140 Broadway, New York,
New York 10005, Telephone: (646) 746–
9700.
Commodity Futures Trading
Commission, 525 West Monroe Street,
Suite 1100 North, Chicago, Illinois
60661, Telephone: (312) 596–0700.
Commodity Futures Trading
Commission, Two Emanuel Cleaver II
Blvd., Suite 300, Kansas City, Missouri
64112, Telephone: (816) 960–7700.
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*
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*
*
Dated: March 29, 2007.
By the Commission.
Eileen A. Donovan,
Acting Secretary of the Commission.
[FR Doc. E7–6190 Filed 4–3–07; 8:45 am]
BILLING CODE 6351–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Praziquantel and Pyrantel
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC61 with RULES
ACTION:
Final rule.
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 use of
chewable tablets containing
praziquantel and pyrantel pamoate in
dogs and puppies for the treatment and
control of various internal parasites.
DATES: This rule is effective April 4,
2007.
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, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Virbac
AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, filed NADA 141–261
for WORMXPLUS (praziquantel and
pyrantel pamoate) Flavored Chewables
and VIRBANTEL (praziquantel and
pyrantel pamoate) Flavored Chewables
that provides for their use in dogs and
puppies for the treatment and control of
VerDate Aug<31>2005
15:40 Apr 03, 2007
Jkt 211001
various internal parasites. The NADA is
approved as of March 13, 2007, and 21
CFR 520.1871 is amended to reflect the
approval.
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 March
13, 2007.
FDA has determined under 21 CFR
25.33(d)(1) 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.
I 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:
I
Authority: 21 U.S.C. 360b.
2. Amend § 520.1871 as follows:
a. Revise the section heading and
paragraphs (a) and (b);
I b. Redesignate paragraph (c) as
paragraph (d) and add new paragraph
(c); and
I c. Revise newly redesignated
paragraphs (d)(1)(i), (d)(1)(iii), and
(d)(2).
The revisions, redesignation, and
addition read as follows:
I
I
§ 520.1871
Praziquantel and pyrantel.
(a) Specifications—(1) Each tablet
contains 18.2 milligrams (mg)
praziquantel and 72.6 mg pyrantel (as
pyrantel pamoate).
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
(2) Each chewable tablet contains 30
mg praziquantel and 30 mg pyrantel
pamoate or 114 mg praziquantel and
114 mg pyrantel pamoate.
(b) Sponsors. See sponsors in
§ 510.600(c) for use as in paragraph (d)
of this chapter.
(1) See No. 000859 for use of tablet
described in paragraph (a)(1) of this
section for use as in paragraph (d)(1) of
this section.
(2) See No. 051311 for use of tablets
described in paragraph (a)(2) of this
section for use as in paragraph (d)(2) of
this section.
(c) Special considerations. See
§ 500.25 of this chapter.
(d) * * *
(1) * * *
(i) Dosage. 1.5 to 1.9 pounds, 1/4
tablet; 2 to 3 pounds, 1/2 tablet; 4 to 8
pounds, 1 tablet; 9 to 12 pounds, 1 1/
2 tablets; 13 to 16 pounds, 2 tablets. If
reinfection occurs, treatment may be
repeated.
*
*
*
*
*
(iii) Limitations. Not for use in kittens
less than 1 month of age or weighing
less than 1.5 pounds. May be given
directly by mouth or in a small amount
of food. Do not withhold food prior to
or after treatment. Consult your
veterinarian before giving to sick or
pregnant animals.
(2) Dogs—(i) Amount. Administer a
minimum dose of 5 mg praziquantel and
5 mg pyrantel pamoate per kilogram
body weight (2.27 mg praziquantel and
2.27 mg pyrantel pamoate per pound
body weight) according to the dosing
tables on labeling.
(ii) Indications for use. For the
treatment and control of roundworms
(Toxocara canis and Toxascaris
leonina), hookworms (Ancylostoma
caninum, Ancylostoma braziliense, and
Uncinaria stenocephala), and
tapeworms (Dipylidium caninum and
Taenia pisiformis) in dogs and puppies.
Dated: March 26, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7–6181 Filed 4–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Melengestrol and Lasalocid
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\04APR1.SGM
Final rule.
04APR1
Agencies
[Federal Register Volume 72, Number 64 (Wednesday, April 4, 2007)]
[Rules and Regulations]
[Page 16270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6181]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 use
of chewable tablets containing praziquantel and pyrantel pamoate in
dogs and puppies for the treatment and control of various internal
parasites.
DATES: This rule is effective April 4, 2007.
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 141-261 for WORMXPLUS (praziquantel and
pyrantel pamoate) Flavored Chewables and VIRBANTEL (praziquantel and
pyrantel pamoate) Flavored Chewables that provides for their use in
dogs and puppies for the treatment and control of various internal
parasites. The NADA is approved as of March 13, 2007, and 21 CFR
520.1871 is amended to reflect the approval.
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 March 13,
2007.
FDA has determined under 21 CFR 25.33(d)(1) 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.
0
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
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Amend Sec. 520.1871 as follows:
0
a. Revise the section heading and paragraphs (a) and (b);
0
b. Redesignate paragraph (c) as paragraph (d) and add new paragraph
(c); and
0
c. Revise newly redesignated paragraphs (d)(1)(i), (d)(1)(iii), and
(d)(2).
The revisions, redesignation, and addition read as follows:
Sec. 520.1871 Praziquantel and pyrantel.
(a) Specifications--(1) Each tablet contains 18.2 milligrams (mg)
praziquantel and 72.6 mg pyrantel (as pyrantel pamoate).
(2) Each chewable tablet contains 30 mg praziquantel and 30 mg
pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate.
(b) Sponsors. See sponsors in Sec. 510.600(c) for use as in
paragraph (d) of this chapter.
(1) See No. 000859 for use of tablet described in paragraph (a)(1)
of this section for use as in paragraph (d)(1) of this section.
(2) See No. 051311 for use of tablets described in paragraph (a)(2)
of this section for use as in paragraph (d)(2) of this section.
(c) Special considerations. See Sec. 500.25 of this chapter.
(d) * * *
(1) * * *
(i) Dosage. 1.5 to 1.9 pounds, 1/4 tablet; 2 to 3 pounds, 1/2
tablet; 4 to 8 pounds, 1 tablet; 9 to 12 pounds, 1 1/2 tablets; 13 to
16 pounds, 2 tablets. If reinfection occurs, treatment may be repeated.
* * * * *
(iii) Limitations. Not for use in kittens less than 1 month of age
or weighing less than 1.5 pounds. May be given directly by mouth or in
a small amount of food. Do not withhold food prior to or after
treatment. Consult your veterinarian before giving to sick or pregnant
animals.
(2) Dogs--(i) Amount. Administer a minimum dose of 5 mg
praziquantel and 5 mg pyrantel pamoate per kilogram body weight (2.27
mg praziquantel and 2.27 mg pyrantel pamoate per pound body weight)
according to the dosing tables on labeling.
(ii) Indications for use. For the treatment and control of
roundworms (Toxocara canis and Toxascaris leonina), hookworms
(Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria
stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis)
in dogs and puppies.
Dated: March 26, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-6181 Filed 4-3-07; 8:45 am]
BILLING CODE 4160-01-S