[Federal Register Volume 72, Number 40 (Thursday, March 1, 2007)]
[Rules and Regulations]
[Pages 9242-9243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 522


New Animal Drugs; Maropitant

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 two new animal drug 
applications (NADAs) filed by Pfizer, Inc. The NADAs provide for the 
veterinary prescription use of maropitant citrate tablets and 
maropitant citrate injectable solution for the management of vomiting 
in dogs.

DATES: This rule is effective March 1, 2007.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 141-262 for CERENIA (maropitant citrate) Tablets. The 
NADA provides for the veterinary prescription use of maropitant citrate 
tablets in dogs for the prevention of acute vomiting and for the 
prevention of vomiting due to motion sickness. The application is 
approved as of January 29, 2007, and 21 CFR part 520 is amended by 
adding new Sec.  520.1315 to reflect the approval.
    Pfizer, Inc., also filed NADA 141-263 for CERENIA (maropitant 
citrate) Injectable Solution, used by veterinary prescription in dogs 
for the prevention and treatment of acute vomiting. The application is 
approved as of January 29, 2007, and 21 CFR part 522 is amended by 
adding new Sec.  522.1315 to reflect the approval.

[[Page 9243]]

    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this original 
approval of NADA 141-262 qualifies for 5 years of marketing exclusivity 
beginning January 29, 2007.
    Under section 512(c)(2)(F)(ii) of the act, this original approval 
of NADA 141-263 qualifies for 3 years of marketing exclusivity 
beginning January 29, 2007.
    The agency has determined under 21 CFR 25.33(d)(1) that these 
actions are of a type that do 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 in 21 CFR Parts 520 and 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 520 and 
522 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


0
2. Section 520.1315 is added to read as follows:


Sec.  520.1315  Maropitant.

    (a) Specifications. Each tablet contains 16, 24, 60, or 160 
milligrams (mg) maropitant as maropitant citrate.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Indications for use and amount. 
For the prevention of acute vomiting, administer a minimum of 2.0 mg 
per kilogram (/kg) body weight once daily for up to 5 consecutive days. 
For the prevention of vomiting due to motion sickness, administer a 
minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive 
days.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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. Section 522.1315 is added to read as follows:


Sec.  522.1315  Maropitant.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) maropitant as maropitant citrate.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 1.0 mg per 
kilogram body weight by subcutaneous injection once daily for up to 5 
consecutive days.
    (2) Indications for use. For the prevention and treatment of acute 
vomiting.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: February 16, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-3402 Filed 2-28-07; 8:45 am]
BILLING CODE 4160-01-S