[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Rules and Regulations]
[Pages 13509-13510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6668]
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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; Propofol
Injection
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 Schering-Plough Animal Health Corp. The
supplemental NADA provides for expanding the indications to include the
use of propofol in cats.
EFFECTIVE DATE: March 19, 1999.
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: Schering-Plough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083, filed supplemental NADA 141-070 that
provides for intravenous use in cats of Rapinovet Anesthetic Injection
(each milliliter contains 10 milligrams of propofol). The product was
previously approved for use in dogs. The drug is used as a single
injection to provide general anesthesia for short procedures, for
induction and maintenance of general anesthesia using incremental doses
to affect, and for induction of general anesthesia where maintenance is
provided by inhalant anesthetics. The drug is limited to use by or on
the order of a licensed veterinarian. The supplemental NADA is approved
as of January 14, 1999, and the regulations are amended in 21 CFR
522.2005 by revising paragraph (b) and by adding paragraph (c)(2) to
reflect the approval. The basis of approval is provided 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, 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)(iii) of the Federal Food, Drug, and
Cosmetic Act, this approval qualifies for a 3-year period of marketing
exclusivity beginning January 14, 1999, because the supplement
application contains substantial evidence of the effectiveness of the
drug involved, or any studies of animal safety, required for the
approval of the application and conducted or sponsored by the
applicant. The 3 years of marketing exclusivity applies only to the new
species (cats) for which the supplemental application was approved.
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 in 21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner
[[Page 13510]]
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: 21 U.S.C. 360b.
2. Section 522.2005 is amended by revising paragraph (b) and by
adding paragraph (c)(2) to read as follows:
Sec. 522.2005 Propofol injection.
* * * * *
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter for
use as in paragraphs (c)(1) and (c)(2) of this section. See No. 000074
in Sec. 510.600(c) of this chapter for use as in paragraph (c)(1) of
this section.
(c) * * *
(2) Cats. (i) The drug is indicated for use as an anesthetic as
follows: As a single injection to provide general anesthesia for short
procedures, for induction and maintenance of general anesthesia using
incremental doses to effect, and for induction of general anesthesia
where maintenance is provided by inhalant anesthetics.
(ii) The drug is administered by intravenous injection as follows:
For induction of general anesthesia without the use of preanesthetics
the dosage is 8.0 to 13.2 milligrams per kilogram (3.6 to 6.0
milligrams per pound). For the maintenance of general anesthesia
without the use of preanesthetics the dosage is 1.1 to 4.4 milligrams
per kilogram (0.5 to 2.0 milligrams per pound). The use of
preanesthetic medication reduces propofol dose requirements.
(iii) Adequate data concerning safe use of propofol in pregnant and
breeding cats have not been obtained. Doses may need adjustment for
geriatric or debilitated patients. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
Dated: February 23, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-6668 Filed 3-18-99; 8:45 am]
BILLING CODE 4160-01-F
