Document ID: FDA-2009-N-0665-0076
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Polysulfated Glycosaminoglycan
Posted Date: 2009-12-21T05:00Z

[Federal Register: December 21, 2009 (Volume 74, Number 243)]
[Rules and Regulations]               
[Page 67815-67816]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de09-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

 
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 additional vial sizes for an injectable 
solution of polysulfated glycosaminoglycan.

DATES: This rule is effective December 21, 2009.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary

[[Page 67816]]

Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8337, 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 (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 additional vial sizes. The application 
is approved as of November 10, 2009, and the regulations are amended in 
21 CFR 522.1850 to reflect the approval.
    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 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 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

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  522.1850, revise paragraph (a) to read as follows:

Sec.  522.1850  Polysulfated glycosaminoglycan.

    (a) Specifications. (1) Each 1-milliliter (mL) ampule of solution 
contains 250 milligrams (mg) polysulfated glycosaminoglycan.
    (2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 
50-mL vials contains 100 mg polysulfated glycosaminoglycan.
* * * * *

    Dated: December 15, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-30222 Filed 12-18-09; 8:45 am]

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