[Federal Register Volume 75, Number 74 (Monday, April 19, 2010)]
[Rules and Regulations]
[Pages 20268-20269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8945]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2010-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs; Change
of Sponsor; Propofol
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 a change of sponsor for a new animal drug
application (NADA) from Intervet, Inc., to Teva Animal Health, Inc.
DATES: This rule is effective April 19, 2010.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068, has informed FDA that it has transferred ownership
of, and all rights and interest in, approved NADA 141-070 for RAPINOVET
(propofol), an
[[Page 20269]]
injectable anesthetic, to Teva Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503. Accordingly, the agency is amending
the regulations in 21 CFR 522.2005 to reflect the transfer of ownership
and a current format.
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.
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
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Revise Sec. 522.2005 to read as follows:
Sec. 522.2005 Propofol.
(a) Specifications. Each milliliter of emulsion contains 10
milligrams (mg) propofol.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 059130 for use as in paragraph (c) of this section.
(2) No. 000074 for use as in paragraphs (c)(1)(i), (c)(2), and
(c)(3) of this section.
(c) Conditions of use in dogs and cats--(1) Amount. The drug is
administered by intravenous injection as follows:
(i) Dogs. For induction of general anesthesia without the use of
preanesthetics the dosage is 5.5 to 7.0 mg per kilogram (mg/kg) (2.5 to
3.2 mg/pound (lb)); for the maintenance of general anesthesia without
the use of preanesthetics the dosage is 1.1 to 3.3 mg/kg (0.5 to 1.5
mg/lb). The use of preanesthetic medication reduces propofol dose
requirements.
(ii) Cats. For induction of general anesthesia without the use of
preanesthetics the dosage is 8.0 to 13.2 mg/kg (3.6 to 6.0 mg/lb). For
the maintenance of general anesthesia without the use of preanesthetics
the dosage is 1.1 to 4.4 mg/kg (0.5 to 2.0 mg/lb). The use of
preanesthetic medication reduces propofol dose requirements.
(2) Indications for use. As a single injection to provide general
anesthesia for short procedures; for induction and maintenance of
general anesthesia using incremental doses to effect; for induction of
general anesthesia where maintenance is provided by inhalant
anesthetics.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: April 13, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-8945 Filed 4-16-10; 8:45 am]
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