[Federal Register: January 11, 2006 (Volume 71, Number 7)]
[Rules and Regulations]
[Page 1689]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja06-4]
[[Page 1689]]
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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;
Hyaluronate Sodium Injection
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 a supplemental new animal drug
application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA
provides for veterinary prescription use of a hyaluronate sodium
solution, formulated with a benzyl alcohol preservative, for
intravenous administration to horses for the treatment of
osteoarthritis.
DATES: This rule is effective January 11, 2006.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail:
melanie.berson@fda.gov.
SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement
to NADA 140-883 that provides for veterinary prescription use of LEGEND
Multi-dose (hyaluronate sodium) Injectable Solution. The supplemental
NADA provides for use of this hyaluronate sodium solution, formulated
with a benzyl alcohol preservative, from a multi-dose vial for
intravenous administration to horses for the treatment of carpal or
fetlock osteoarthritis. The supplemental NADA is approved as of
December 15, 2005, and the regulations are amended in 21 CFR 522.1145
to reflect the approval and a current format. 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.
The agency 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 Subject in 21 CFR Part 522
Animal drugs.
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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.
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2. Section 522.1145 is amended by revising paragraph (e) to read as
follows:
Sec. 522.1145 Hyaluronate sodium injection.
* * * * *
(e)(1) Specifications. Each milliliter of solution contains:
(i) 10 milligrams (mg) hyaluronate sodium; or
(ii) 10 mg hyaluronate sodium with benzyl alcohol as a
preservative.
(2) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(3) Conditions of use in horses--(i) Amount. 20 mg of the product
described in paragraph (e)(1)(i) of this section by intra-articular
injection into the carpus or fetlock; or 40 mg of the product described
in paragraph (e)(1)(i) or (e)(1)(ii) of this section by slow
intravenous injection into the jugular vein. Treatment may be repeated
at weekly intervals for a total of three treatments.
(ii) Indications for use. For treatment of carpal or fetlock joint
dysfunction due to noninfectious synovitis associated with equine
osteoarthritis.
(iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
* * * * *
Dated: January 4, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 06-229 Filed 1-10-06; 8:45 am]
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