Justia Regulation Tracker

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[Federal Register: October 5, 2007 (Volume 72, Number 193)]
[Rules and Regulations]               
[Page 56896]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc07-6]                         

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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.

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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 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.

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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

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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. 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

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