[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Rules and Regulations]
[Pages 54804-54806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23891]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Oxytetracycline Injection

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 a hybrid new animal drug 
application (NADA) filed by Norbrook Laboratories, Ltd. The NADA 
provides for the prescription and over-the-counter use of a 300 
milligram per milliliter (mg/mL) oxytetracycline injectable solution 
for the treatment of various bacterial diseases of cattle and swine, 
and for the control of respiratory disease in cattle at high risk of 
developing bovine respiratory disease (BRD).

DATES: This rule is effective September 19, 2003.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry, BT35 6JP, Northern Ireland, filed NADA 141-143, a hybrid 
application that provides for veterinary prescription use of TETRADURE 
300 (oxytetracycline) Injection and over-the-counter use of 
Oxytetracycline Injection 300 mg/mL for the treatment of various 
bacterial diseases of cattle and swine. Norbrook Laboratories' 
TETRADURE 300 Injection and Oxytetracycline Injection 300 mg/mL are 
approved as generic copies of Pfizer's LIQUAMYCIN LA-200, approved 
under NADA 113-232. TETRADURE 300 Injection is also indicated for the 
control of respiratory disease in cattle at high risk of developing BRD 
associated with Mannheimia (Pasteurella) haemolytica. The application 
is approved as of July 25, 2003, and the regulations in part 522 (21 
CFR part 522) are amended to reflect the approval by revising Sec.  
522.1660 and by adding Sec.  522.1660b. The basis of approval is 
discussed in the freedom of information summary.
    NADA 141-143 is a hybrid application as defined in the Center for 
Veterinary Medicine's Seventh Generic Animal Drug Policy Letter, dated 
March

[[Page 54805]]

20, 1991. The data submitted in support of this hybrid NADA satisfy the 
requirements of section 512(b)(1) and (b)(2) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 360b(b)(1) and (b)(2)) and 21 CFR 
part 514 of the regulations. This hybrid application relies on the 
approval of the pioneer animal drug product, a 200 mg/mL solution of 
oxytetracycline, to the extent that such reliance is allowed under 
section 512(n) of the act, to establish the safety and effectiveness of 
the active ingredient, oxytetracycline. This is the section 512(b)(2) 
portion of the hybrid application. It also contains data to support a 
change from the pioneer product formulation to a generic product of 
greater concentration, 300 mg/mL; to support use in cattle at a higher 
dosage of 13.6 mg/lb bodyweight; and to support use for the control of 
respiratory disease in cattle at high risk of developing BRD. These are 
the section 512(b)(1) portions of the hybrid application.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a 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.
    Under section 512(c)(2)(F)(ii) of the act (21 U.S.C. 
360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing 
exclusivity beginning July 25, 2003. This marketing exclusivity applies 
only to the increase in formulation concentration to 300 mg/mL, to the 
veterinary prescription use of the product in cattle at dose ranges of 
9 to 13.6 mg/lb bodyweight, and for the control of respiratory disease 
in cattle at high risk of developing BRD associated with Mannheimia 
(Pasteurella) haemolytica for which new data were required.
    The agency has determined under 21 CFR 25.33(a)(1) and (d)(5) 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 Subject in 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 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. Section 522.1660 is amended by revising the section heading to read 
as follows:


Sec.  522.1660  Oxytetracycline injection, 200 milligram/milliliter.

0
3. Section 522.1660a is added to read as follows:


Sec.  522.1660a  Oxytetracycline injection, 300 milligram/milliliter.

    (a) Specifications. Each milliliter (mL) of solution contains 300 
milligrams (mg) oxytetracycline base.
    (b) Sponsor. See No. 055529 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.500 of this chapter.
    (d) Special considerations. When labeled for use as in paragraph 
(e)(1)(i)(D) or (e)(1)(i)(E) of this section, labeling shall also bear 
the following: ``Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.''.
    (e) Conditions of use--(1) Beef cattle, nonlactating dairy cattle, 
and calves including preruminating (veal) calves--(i) Amounts and 
indications for use--(A) 3 to 5 mg per pound of bodyweight (mg/lb BW) 
per day (/day) intramuscularly, subcutaneously, or intravenously for 
treatment of pneumonia and shipping fever complex associated with 
Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused 
by Fusobacterium necrophorum, bacterial enteritis (scours) caused by 
Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, 
leptospirosis caused by Leptospira pomona, wound infections and acute 
metritis caused by Staphylococcus spp. and Streptococcus spp.
    (B) 5 mg/lb BW/day intramuscularly, subcutaneously, or 
intravenously for treatment of severe foot-rot, and advanced cases of 
other indicated diseases.
    (C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage 
where retreatment of calves and yearlings for bacterial pneumonia is 
impractical or for treatment of infectious bovine keratoconjunctivitis 
(pinkeye) caused by Moraxella bovis.
    (D) 9 to 13.6 mg/lb BW intramuscularly or subcutaneously as single 
dosage where retreatment of calves and yearlings for bacterial 
pneumonia is impractical or for treatment of infectious bovine 
keratoconjunctivitis (pinkeye) caused by Moraxella bovis.
    (E) 13.6 mg/lb BW intramuscularly or subcutaneously as a single 
dosage for control of respiratory disease in cattle at high risk of 
developing BRD associated with Mannheimia (Pasteurella) haemolytica.
    (ii) Limitations. Treatment should be continued 24 to 48 hours 
following remission of disease signs, however, not to exceed a total of 
four consecutive days. Do not inject more than 10 mL per site in adult 
cattle, reducing the volume according to age and body size to 1 to 2 mL 
in small calves. Exceeding the highest recommended level of drug/lb BW/
day, administering more than the recommended number of treatments, and/
or exceeding 10 mL intramuscularly or subcutaneously per injection site 
may result in antibiotic residues beyond the withdrawal time. Rapid 
intravenous administration in cattle may result in animal collapse. 
Oxytetracycline should be administered intravenously slowly over a 
period of at least 5 minutes. Discontinue treatment at least 28 days 
prior to slaughter. Not for use in lactating dairy animals.
    (2) Swine--(i) Amount. 3 to 5 mg/lb BW/day; 9 mg/lb BW as a single 
dosage where retreatment for pneumonia is impractical. Sows: Administer 
once 3 mg/lb BW, approximately 8 hours before farrowing or immediately 
after completion of farrowing.
    (ii) Indications for use. For treatment of bacterial enteritis 
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused 
by Pasteurella multocida, and leptospirosis caused by Leptospira 
pomona. Sows: as an aid in control of infectious enteritis (baby pig 
scours, colibacillosis) in suckling pigs caused by E. coli.
    (iii) Limitations. Administer intramuscularly. Treatment should be 
continued 24 to 48 hours beyond remission of disease signs, however, 
not to exceed a total of 4 consecutive days. Exceeding the highest 
recommended level of drug/lb BW/day, administering more than the 
recommended number of treatments, and/or exceeding 5 mL intramuscularly 
per injection site may result in antibiotic residues beyond the

[[Page 54806]]

withdrawal time. Discontinue treatment at least 28 days prior to 
slaughter.

    Dated: August 27, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-23891 Filed 9-18-03; 8:45 am]
BILLING CODE 4160-01-S