[Federal Register Volume 61, Number 203 (Friday, October 18, 1996)]
[Rules and Regulations]
[Page 54333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26686]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 intramuscular (i.m.) use of polysulfated
glycosaminoglycan in horses for the treatment of noninfectious
degenerative and/or traumatic joint dysfunction and associated lameness
of the hock joint.
EFFECTIVE DATE: October 18, 1996.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, 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, Shirley, NY 11967, is the sponsor of NADA 140-901,
which provides for use of Adequan i.m. (500 milligrams of
polysulfated glycosaminoglycan per 5 milliliters of sterile aqueous
solution). The NADA provides for the intra-articular and intramuscular
use of polysulfated glycosaminoglycan in horses for the treatment of
noninfectious degenerative and/or traumatic joint dysfunction and
associated lameness of the carpal joint. The firm has filed a
supplement to the NADA that provides for intramuscular use of the drug
product in horses for treatment of the same conditions of the hock
joint. The supplemental NADA is approved as of September 13, 1996, and
the regulations are amended in 21 CFR 522.1850 to reflect the approval.
The basis for approval is discussed in the freedom of information
summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 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.
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 revising paragraph (c)(1) and the
first sentence of paragraphs (c)(2)(i) and (c)(2)(ii) to read as
follows:
Sec. 522.1850 Polysulfated glycosaminoglycan.
* * * * *
(c) Conditions of use--horses. (1) Indications for use.
Polysulfated glycosaminoglycan is for the treatment of noninfectious
degenerative and/or traumatic joint dysfunction and associated lameness
of the carpal and hock joints in horses.
(2) Amount--(i) Intra-articular use (carpal): 250 milligrams once a
week for 5 weeks.
* * * * *
(ii) Intramuscular use (carpal and hock): 500 milligrams every 4
days for 28 days. * * *
* * * * *
Dated: October 4, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-26686 Filed 10-17-96; 8:45 am]
BILLING CODE 4160-01-F
