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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-127 undetermined TRADEMARK Injectable - original approval

Approval Date: May 9, 1996

I. GENERAL INFORMATION

NADA200-127
Sponsor:The Upjohn Company
Agricultural Division
Kalamazoo, Michigan 49001-0199
Generic Name:spectinomycin hydrochloride (dihydrochloride pentahydrate) sterile solution
Trade Name:undetermined TRADEMARK Injectable
Marketing Status:Over the Counter (OTC)

 

II. & III. INDICATIONS FOR USE AND DOSAGE FORM, ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE

A.DOSAGE FORMInjectable
B.ROUTE OF ADMINISTRATIONSubcutaneous injection only.
C.RECOMMENDED DOSAGES AND INDICATIONS FOR USE:TURKEY POULTS
INDICATIONSDOSAGE
As an aid in the control of Chronic Respiratory Disease CRD) associated with Escherichia coli.5.0 mg
As an aid in the control of airsacculitis associated with Mycoplasma meleagridis sensitive to spectinomycin.10.0 mg
CHICKS
INDICATIONSDOSAGE
As an aid in the control of mortality and to lessenseverity of infections causedby Mycoplasma synoviae,Salmonella typhimurium, Salmonella infantis, and Eschericia coli.2.5 to 5.0 mg

 

IV. & V. EFFECTIVENESS AND ANIMAL SAFETY

Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent 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 and conducts a tissue residue study to establish the withdrawal time for the generic product. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (60 FR 11097, March 1, 1995, Bioequivalence Guideline (draft) 1994).

Based upon the formulation characteristics of the generic product, The Upjohn Company was granted a waiver from conducting an in vivo bioequivalence study for spectinomycin hydrochloride. The generic and pioneer products are injectable products with the same active ingredients and no differences in the inactive ingredients which would affect absorption of the active ingredients.

 

VI. HUMAN FOOD SAFETY

Tolerance
Spectinomycin was approved based on the negligible tolerance concept. A negligible tolerance has been applied to animal drug residues when the supporting toxicological data are of subchronic (90-day) duration. The "negligible tolerance" concept is based on two precepts: (1) the residue present is at a level of insignificance and (2) the safety of the residue is supported by limited toxicological data. The upper level for a drug residue to qualify for "negligible tolerance" is considered customarily to be 0.1 part per million (ppm) residue in tisssue. Therefore, the tolerance for spectinomycin residues in edible tissue is the same for all species in which the drug is approved. Accordingly, 21 CFR 556.600 is amended to apply the tolerance of 0.1 ppm to edible turkey tissues.

The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.1 ppm is established for negligible residues of spectinomycin in the uncooked edible tissues of chickens and turkeys under 21 CFR 556.600.

Withdrawal Time
A withdrawal period for the use of spectinomycin in 1 to 3-day-old turkey poults and newly-hatched chicks is not required.

Regulatory Method
A regulatory method for residues for the use of spectinomycin in 1 to 3-day-old turkey poults and newly-hatched chicks is not required

 

VII.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 undetermined TRADEMARK Injectable (spectinomycin di-hydrochloride pentahydrate) when used under the proposed conditions of use, is safe and effective for its labeled indications.

 

VIII. LABELING (Attached)

The following generic labeling and currently approved pioneer labeling are attached.

  1. Generic labels
    • The Upjohn Company's Package Insert
    • The Upjohn Company's bottle label
    • The Upjohn Company's Carton Label
  2. Pioneer label
    • Sanofi Animal Health's Package Insert
    • Sanofi Animal Health's bottle label

Copies of applicable labels may be obtained by writing to the:

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857

Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.