Approval Date: May 8, 1996
I. GENERAL INFORMATION
Pennfield Oil Co
14040 Industrial Road
Omaha, Nebraska 68144
- Established Name: oxytetracycline injection
- Trade/Proprietary Name: Oxytetracycline 200
- Dosage Form: sterile injectable solution
- How Supplied: 500 mL bottles
- How Dispensed: OTC
- Amount of Active Ingredient: 200 mg/mL
- Route of Administration: Intramuscular in swine, intramuscular or intravenous in cattle
- Species: Beef cattle, non-lactating dairy cattle, and swine
- Pioneer Product / "Listed" Product: Liquamycin® LA-200; oxytetracycline injection; NADA #113-232; Pfizer
Oxytetracycline 200 is intended for use in the treatment of the following diseases in beef cattle, nonlactating dairy cattle and swine when due to oxytetracycline susceptible organisms.
- Oxytetracycline 200 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline.
- In swine, Oxytetracycline 200 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona.
- In sows, Oxytetracycline 200 is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
- Oxytetracycline 200 is to be administered by intramuscular or intravenous injection to beef cattle and nonlactating dairy cattle.
- A single dose of 9 mg of Oxytetracycline 200 per pound of body weight administered intramuscularly is recommended in the treatment of the following conditions: 1) bacterial pneumonia caused by Pasteurella spp. (shipping fever) in calves and yearlings, where retreatment is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable; 2) infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.
- Oxytetracycline 200 can also be administered by intravenous or intramuscular injection at a level of 3 to 5 mg of oxytetracycline per pound of body weight per day. In the treatment of severe foot rot and advanced cases of other indicated diseases, a dosage level of 5 mg per pound of body weight per day is recommended. Treatment should be continued 24 to 48 hours following remission of disease signs; however, not to exceed a total of four consecutive days. Consult your veterinarian if improvement is not noted within 24 to 48 hours of the beginning of treatment.
- A single dose of 9 mg of Oxytetracycline 200 per pound of body weight administered intramuscularly is recommended in the treatment of bacterial pneumonia caused by Pasteurella multocida in swine, where retreatment is impractical due to husbandry conditions or where repeated restraint is inadvisable.
- Oxytetracycline 200 can be administered by intramuscular injection at a level of 3 to 5 mg of oxytetracycline per pound of body weight per day. Treatment should be continued 24 to 48 hours following remission of diseases signs; however, not to exceed a total of four consecutive days. Consult your veterinarian if improvement is not noted within 24 to 48 hours of the beginning of treatment.
- For sows, administer once intramuscularly 3 mg of oxytetracycline per pound of body weight approximately 8 hours before farrowing or immediately after completion of farrowing.
- For swine weighing 25 lb of body weight and under, Oxytetracycline 200 should be administered undiluted for treatment at 9 mg/lb but should be administered diluted for treatment at 3 or 5 mg/lb.
IV. TARGET ANIMAL SAFETY and DRUG EFFECTIVENESS
Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and human food safety data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990).
Based upon the formulation characteristics of the generic product, Pennfield Oil Company was granted a waiver from conducting an in vivo bioequivalence study for oxytetracycline injection. The generic and pioneer products contain the same active and inactive ingredients and are parenteral solutions.
V. HUMAN FOOD SAFETY
The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.1 ppm is established for the uncooked edible tissues of cattle, beef calves, nonlactating dairy cattle, dairy calves, and swine under 21 CFR 556.500.
When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal times are those previously assigned to the pioneer product. The withdrawal time for oxytetracycline injection is established under 21 CFR 522.1660: 28 days for beef cattle, nonlactating dairy cattle, and swine.
Regulatory Method for Residues
The analytical method for detection of residues of the drug is the cylinder plate microbiological test using Bacillus cereus var. mycoides (ATCC 11778) as outlined in the "Antibiotic Residues in Milk, Dairy Products and Animal Tissues: Methods, Reports, and Protocols" October 1968, National Center for Antibiotic and Insulin Analysis, FDA, Washington, D.C. 20204.
VI. AGENCY CONCLUSIONS
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that oxytetracycline injection when used under the proposed conditions of use, is safe and effective for its labeled indications.
The following generic labeling and currently approved pioneer labeling are attached.
- Facsimile bottle label and insert for generic oxytetracycline - Oxytetracycline 200 (oxytetracycline injection) 200 mg/mL, 500 mL bottles
- Approved pioneer bottle label and insert for oxytetracycline - Liquamycin® LA-200 (oxytetracycline injection) 200 mg/mL, 500 mL bottles
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855