[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Pages 260-261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22510]


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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: 
[email protected].

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) * * *

------------------------------------------------------------------------
            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) * * *

------------------------------------------------------------------------
      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