Implantation or Injectable Dosage Form New Animal Drugs; Polysulfated Glycosaminoglycan, 56896 [E7-19729]
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56896
Federal Register / Vol. 72, No. 193 / Friday, October 5, 2007 / Rules and Regulations
Collegeville, PA, Perkiomen Valley, RNAV
(GPS) RWY 9, Amdt 1
Du Bois, PA, Du Bois-Jefferson County,
RNAV (GPS) RWY 7, Orig
Du Bois, PA, Du Bois-Jefferson County, VOR/
DME RNAV OR GPS RWY 7, Amdt 1,
CANCELLED
Du Bois, PA, Du Bois-Jefferson County,
Takeoff Minimums and Obstacle DP, Orig
Cotulla, TX, Cotulla-La Salle County, VOR–
A, Amdt 13
Cotulla, TX, Cotulla-La Salle County, Takeoff
Minimums and Obstacle DP, Orig
Farmville, VA, Farmville Regional, Takeoff
Minimums and Obstacle DP, Orig
Huntington, WV, Tri-State/Milton J. Ferguson
Field, ILS OR LOC RWY 12, Amdt 12
Huntington, WV, Tri-State/Milton J. Ferguson
Field, ILS OR LOC RWY 30, Amdt 5
Huntington, WV, Tri-State/Milton J. Ferguson
Field, RNAV (GPS) RWY 12, Amdt 1
Huntington, WV, Tri-State/Milton J. Ferguson
Field, RADAR–1, Amdt 6
Huntington, WV, Tri-State/Milton J. Ferguson
Field, Takeoff Minimums and Obstacle DP,
Orig
[FR Doc. E7–19240 Filed 10–4–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
noninfectious degenerative and/or
traumatic joint disease. The
supplemental NADA provides for a
revised food safety warning for use in
horses. The application is approved as
of September 10, 2007, and the
regulations are amended in 21 CFR
522.1850 to reflect the approval and a
current format.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under
§ 25.33(a)(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.
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Polysulfated
Glycosaminoglycan
Food and Drug Administration,
HHS.
yshivers on PROD1PC62 with RULES
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Luitpold Pharmaceuticals, Inc. The
supplemental NADA provides for a
revised food safety warning on labeling
for an injectable solution of polysulfated
glycosaminoglycan used in horses.
DATES: This rule is effective October 5,
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: Luitpold
Pharmaceuticals, Inc., Animal Health
Division, Shirley, NY 11967, filed a
supplement to NADA 140–901 for
ADEQUAN i.m. (polysulfated
glycosaminoglycan), an injectable
solution approved for use in horses and
dogs by veterinary prescription for
VerDate Aug<31>2005
15:23 Oct 04, 2007
Jkt 214001
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
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 522 is amended as follows:
New Animal Drugs; Ractopamine
I
ACTION:
Dated: September 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–19729 Filed 10–4–07; 8:45 am]
List of Subjects in 21 CFR Parts 522
Food and Drug Administration
AGENCY:
(ii) Amount—(A) Intra-articular use
(carpal): 250 mg once a week for 5
weeks.
(B) Intramuscular use (carpal and
hock): 500 mg every 4 days for 28 days.
(iii) Limitations. Do not use in horses
intended for human consumption.
(2) Dogs—(i) Indications for use. For
control of signs associated with
noninfectious degenerative and/or
traumatic arthritis of canine synovial
joints.
(ii) Amount. 2 mg per pound of body
weight by intramuscular injection twice
weekly for up to 4 weeks (maximum of
8 injections).
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Revise § 522.1850 to read as
follows:
I
§ 522.1850 Polysulfated
glycosaminoglycan.
(a) Specifications. Each 1-milliliter
(mL) ampule of solution contains 250
milligrams (mg) polysulfated
glycosaminoglycan; each 5-mL ampule
or vial contains 500 mg polysulfated
glycosaminoglycan.
(b) Sponsor. See No. 010797 in
§ 510.600(c) of this chapter.
(c) Special considerations. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(d) Conditions of use—(1) Horses—(i)
Indications for use. For the treatment of
noninfectious degenerative and/or
traumatic joint dysfunction and
associated lameness of the carpal and
hock joints in horses.
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
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 a supplemental new animal
drug application (NADA) filed by
Elanco Animal Health. The
supplemental NADA provides for an
increased level of monensin in four-way
combination Type C medicated feeds
containing ractopamine, melengestrol,
monensin, and tylosin for heifers fed in
confinement for slaughter, a revision to
bacterial pathogen nomenclature, and
an increase in liver tolerance.
DATES: This rule is effective October 5,
2007.
FOR FURTHER INFORMATION CONTACT:
Suzanne J. Sechen, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0221, email: suzanne.sechen@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141–233 that
provides for use of OPTAFLEXX
(ractopamine hydrochloride), MGA
(melengestrol acetate), RUMENSIN
(monensin), and TYLAN (tylosin
phosphate) Type A medicated articles to
E:\FR\FM\05OCR1.SGM
05OCR1
]]>Agencies
[Federal Register Volume 72, Number 193 (Friday, October 5, 2007)]
[Rules and Regulations]
[Page 56896]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19729]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Polysulfated Glycosaminoglycan
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 a supplemental new animal drug
application (NADA) filed by Luitpold Pharmaceuticals, Inc. The
supplemental NADA provides for a revised food safety warning on
labeling for an injectable solution of polysulfated glycosaminoglycan
used in horses.
DATES: This rule is effective October 5, 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: Luitpold Pharmaceuticals, Inc., Animal
Health Division, Shirley, NY 11967, filed a supplement to NADA 140-901
for ADEQUAN i.m. (polysulfated glycosaminoglycan), an injectable
solution approved for use in horses and dogs by veterinary prescription
for noninfectious degenerative and/or traumatic joint disease. The
supplemental NADA provides for a revised food safety warning for use in
horses. The application is approved as of September 10, 2007, and the
regulations are amended in 21 CFR 522.1850 to reflect the approval and
a current format.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The agency has determined under Sec. 25.33(a)(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 Parts 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Revise Sec. 522.1850 to read as follows:
Sec. 522.1850 Polysulfated glycosaminoglycan.
(a) Specifications. Each 1-milliliter (mL) ampule of solution
contains 250 milligrams (mg) polysulfated glycosaminoglycan; each 5-mL
ampule or vial contains 500 mg polysulfated glycosaminoglycan.
(b) Sponsor. See No. 010797 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(d) Conditions of use--(1) Horses--(i) Indications for use. For the
treatment of noninfectious degenerative and/or traumatic joint
dysfunction and associated lameness of the carpal and hock joints in
horses.
(ii) Amount--(A) Intra-articular use (carpal): 250 mg once a week
for 5 weeks.
(B) Intramuscular use (carpal and hock): 500 mg every 4 days for 28
days.
(iii) Limitations. Do not use in horses intended for human
consumption.
(2) Dogs--(i) Indications for use. For control of signs associated
with noninfectious degenerative and/or traumatic arthritis of canine
synovial joints.
(ii) Amount. 2 mg per pound of body weight by intramuscular
injection twice weekly for up to 4 weeks (maximum of 8 injections).
Dated: September 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-19729 Filed 10-4-07; 8:45 am]
BILLING CODE 4160-01-S
