[Federal Register Volume 69, Number 229 (Tuesday, November 30, 2004)]
[Rules and Regulations]
[Pages 69523-69524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26380]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 522


New Animal Drugs; Meloxicam

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 supplemental new animal 
drug applications (NADAs) filed by Boehringer Ingelheim Vetmedica, Inc. 
The first supplemental NADA provides for use of meloxicam injectable 
solution in cats for control of postoperative pain and inflammation 
associated with orthopedic surgery, ovariohysterectomy, and castration 
when administered prior to surgery. It also provides revised dosage 
labeling for this product in dogs. The other supplemental NADA provides 
revised dosage labeling for use of meloxicam oral suspension in dogs.

DATES: This rule is effective November 30, 2004.

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: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Hwy., St. Joseph, MO 64506-2002, filed a supplement to NADA 
141-219 that provides for use of METACAM (meloxicam) Solution for 
Injection in cats for control of postoperative pain and inflammation 
associated with orthopedic surgery, ovariohysterectomy, and castration 
when administered prior to surgery, and also revises dosage information 
for use of this product in dogs. Boehringer Ingelheim Vetmedica, Inc., 
also filed a supplement to NADA 141-213 that provides revised dosage 
information for use of METACAM (meloxicam) Oral Suspension in dogs. The 
supplemental NADAs are approved as of October 28, 2004, and the 
regulations are amended in 21 CFR 520.1350 and 522.1367 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summaries.
    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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), the supplemental 
approval of meloxicam injectable solution for use in cats qualifies for 
3 years of marketing exclusivity beginning October 28, 2004.
    The agency has determined under 21 CFR 25.33(d)(5) 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 520.1350 is amended by revising paragraph (c)(1) to read as 
follows:


Sec.  520.1350  Meloxicam.

* * * * *
    (c) * * *
    (1) Amount. Administer orally as a single dose at 0.09 mg per pound 
(mg/lb) body weight (0.2 mg per kilogram (mg/kg)) on the first day of 
treatment. For all treatment after day 1, administer 0.045 mg/lb (0.1 
mg/kg) body weight once daily.
* * * * *

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 522.1367 is amended by revising paragraph (c) to read as 
follows:


Sec.  522.1367  Meloxicam.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.09 mg per 
pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) by intravenous 
or subcutaneous injection on the first day of treatment. For treatment 
after day 1, administer meloxicam suspension orally at 0.045 mg/lb (0.1 
mg/kg) body weight once daily as in Sec.  520.1350(c) of this chapter.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.14 mg/lb (0.3 mg/kg) body weight 
as a single, one-time subcutaneous injection.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, 
and castration when administered prior to surgery.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


[[Page 69524]]


    Dated: November 18, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-26380 Filed 11-29-04; 8:45 am]
BILLING CODE 4160-01-S