[Federal Register: January 4, 2007 (Volume 72, Number 2)]
[Rules and Regulations]
[Page 260-261]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja07-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
Implantation or Injectable Dosage Form New Animal Drugs; Doxapram
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 an abbreviated new animal drug
application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The
ANADA provides for the use of doxapram hydrochloride injectable
solution in dogs, cats, and horses to stimulate respiration during and
after general anesthesia.
DATES: This rule is effective January 4, 2007.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Modern Veterinary Therapeutics, LLC, 18301
SW. 86th Ave., Miami, FL 33157, filed ANADA 200-435 that provides for
use of RESPIRAM (doxapram hydrochloride), an injectable solution, in
dogs, cats, and horses to stimulate respiration during and after
general anesthesia. Modern Veterinary Therapeutics, LLC's RESPIRAM is
approved as a generic copy of DOPRAM-V Injectable, sponsored by Fort
Dodge Animal Health, Division of Wyeth, under NADA 034 879. The ANADA
is approved as of November 21, 2006, and the regulations are amended in
21 CFR 522.775 to reflect the approval and a current format. The basis
of approval is discussed in the freedom of information summary.
In addition, Modern Veterinary Therapeutics, LLC, has not been
previously listed in the animal drug regulations as a sponsor of an
approved application. Accordingly, 21 CFR 510.600(c) is being amended
to add entries for this firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a
[[Page 261]]
summary of safety and effectiveness data and information submitted to
support approval of this application may be seen in the Division of
Dockets Management (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.
The agency has determined under 21 CFR 25.33(a)(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.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
Animal drugs.
0
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
0
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.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add a new entry for ``Modern Veterinary Therapeutics, LLC''; and in the
table in paragraph (c)(2) numerically add a new entry for ``015914'' to
read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * * *
Modern Veterinary Therapeutics, LLC, 18301 015914
SW. 86th Ave., Miami, FL 33157.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
015914 Modern Veterinary Therapeutics, LLC, 18301
SW. 86th Ave., Miami, FL 33157
* * * * *
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. Revise Sec. 522.775 to read as follows:
Sec. 522.775 Doxapram.
(a) Specifications. Each milliliter of solution contains 20
milligrams (mg) doxapram hydrochloride.
(b) Sponsor. See Nos. 000856 and 015914 in Sec. 510.600(c) of this
chapter.
(c) Conditions of use--(1) Amount. For intravenous use in dogs and
cats at a dose of 2\1/2\ to 5 mg per pound (/lb) body weight in
barbiturate anesthesia, 0.5 mg/lb in inhalation anesthesia; for
intravenous use in horses at 0.25 mg/lb body weight in barbiturate
anesthesia, 0.2 mg/lb in inhalation anesthesia, 0.25 mg/lb with chloral
hydrate with or without magnesium sulfate; for subcutaneous,
sublingual, or umbilical vein administration in neonate puppies at a
dose rate of 1 to 5 mg; for subcutaneous or sublingual use in neonate
kittens at 1 to 2 mg. Dosage may be repeated in 15 to 20 minutes if
necessary.
(2) Indications for use. Administer to dogs, cats, and horses to
stimulate respiration during and after general anesthesia; or to speed
awakening and return of reflexes after anesthesia. Administer to
neonate dogs and cats to initiate respiration following dystocia or
caesarean section; or to stimulate respiration following dystocia or
caesarean section.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: December 19, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-22510 Filed 12-29-06; 8:45 am]
BILLING CODE 4160-01-S