[Federal Register Volume 62, Number 165 (Tuesday, August 26, 1997)]
[Rules and Regulations]
[Pages 45157-45158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22623]
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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 new animal drug application
(NADA) filed by Luitpold Pharmaceuticals, Inc. The NADA provides for
intramuscular injection of polysulfated glycosaminoglycan for dogs for
control of signs associated with noninfectious degenerative and/or
traumatic arthritis of canine synovial joints.
EFFECTIVE DATE: August 26, 1997.
FOR FURTHER INFORMATION CONTACT: Ellen M. Buck, Center For Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1617.
SUPPLEMENTARY INFORMATION: Luitpold Pharmaceuticals, Inc., Animal
Health Division, 1 Luitpold Dr., Shirley, NY 11967, filed NADA 141-038
that
[[Page 45158]]
provides for intramuscular use of Adequan Canine
(polysulfated glycosaminoglycan) for dogs for control of signs
associated with noninfectious degenerative and/or traumatic arthritis
of canine synovial joints. The drug is limited to use by or on the
order of a licensed veterinarian. The NADA is approved as of July 15,
1997, and the regulations are amended in 21 CFR 522.1850 by adding new
paragraph (d) to reflect the approval. 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 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 Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
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, this approval qualifies for 3 years of marketing
exclusivity beginning July 15, 1997, because the application contains
substantial evidence of the effectiveness of the drug involved, studies
of animal safety or, in the case of food-producing animals, human food
safety studies (other than bioequivalence or residue studies) required
for approval of the application and conducted or sponsored by the
applicant.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 522
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:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 522.1850 is amended by adding new paragraph (d) to read
as follows:
Sec. 522.1850 Polysulfated gylcosaminoglycan.
* * * * *
(d) Conditions of use--dogs--(1) Indications for use. For control
of signs associated with noninfectious degenerative and/or traumatic
arthritis of canine synovial joints.
(2) Dosage. 2 milligrams per pound of body weight by intramuscular
injection.
(3) Limitations. Administer intramuscularly twice weekly for up to
4 weeks (maximum of 8 injections). Do not exceed recommended dose or
regimen. Do not mix with other drugs or solvents. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
Dated: August 6, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-22623 Filed 8-25-97; 8:45 am]
BILLING CODE 4160-01-F
