[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44382-44383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22224]
-----------------------------------------------------------------------
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
Implantation or Injectable Dosage Form New Animal Drugs;
Deslorelin Acetate
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 new animal drug application
(NADA) filed by Peptech Animal Health Pty, Ltd. The NADA provides for
veterinary prescription use of deslorelin acetate implants in horses
and ponies for inducing ovulation in estrous mares with an ovarian
follicle greater than 30 millimeters (mm) in diameter.
EFFECTIVE DATE: August 19, 1998.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1612.
SUPPLEMENTARY INFORMATION: Peptech Animal Health Pty, Ltd., 35-41
Waterloo Rd., North Ryde, New South Wales 2113, Australia, filed NADA
141-044 that provides for veterinary prescription use of 2.1 milligrams
deslorelin acetate (OvuplantTM) implant to induce ovulation
within 48 hours in estrous mares with an ovarian follicle greater than
30 mm in diameter. Follicular size should be determined by rectal
palpation and/or ultrasonography prior to treatment. NADA 144-044 is
approved as of June 18, 1998, and the regulations are amended by adding
Sec. 522.533 to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
Peptech Animal Health Pty, Ltd., has not been previously listed in
the animal drug regulations as the sponsor of an approved application.
At this time, 21 CFR 510.600(c)(1) and (c)(2) are amended by adding a
new listing to reflect the sponsor.
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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning June 18, 1998, because no
active ingredient (including any salt or ester of the active
ingredient) has been approved in any other application.
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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding an entry for ``Peptech Animal Health Pty, Ltd.''
and in the table in paragraph (c)(2) by numerically adding an entry for
``064288'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 44383]]
----------------------------------------------------------------------------------------------------------------
Firm name and address Drug labeler code
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Peptech Animal Health Pty, Ltd., 35-41 Waterloo Rd., 064288
North Ryde, New South Wales 2113, Australia
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
(2) * * *
----------------------------------------------------------------------------------------------------------------
Drug labeler code Firm name and address
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
064288 Peptech Animal Health Pty, Ltd., 35-41 Waterloo Rd.,
North Ryde, New South Wales 2113, Australia
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
4. Section 522.533 is added to read as follows:
Sec. 522.533 Deslorelin acetate.
(a) Specifications. Each implant contains 2.1 milligrams deslorelin
acetate.
(b) Sponsor. See 064288 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use--(1) Horses and ponies--(i) Amount. One
implant per mare.
(ii) Indications for use. For inducing ovulation within 48 hours
in estrous mares with an ovarian follicle greater than 30 millimiters
in diameter. Follicular size should be determined by rectal palpation
and/or ultrasonography prior to treatment.
(iii) Limitations. Administer subcutaneously in the neck. Not for
use in horses or ponies intended for food. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
Dated: August 3, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-22224 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F