Approval Date: May 9, 1996
I. GENERAL INFORMATION
The Upjohn Company
Kalamazoo, Michigan 49001-0199
spectinomycin hydrochloride (dihydrochloride pentahydrate) sterile solution
undetermined TRADEMARK Injectable
Over the Counter (OTC)
II. & III. INDICATIONS FOR USE AND DOSAGE FORM, ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE
ROUTE OF ADMINISTRATION
Subcutaneous injection only.
RECOMMENDED DOSAGES AND INDICATIONS FOR USE:
|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|
|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
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.
A withdrawal period for the use of spectinomycin in 1 to 3-day-old turkey poults and newly-hatched chicks is not required.
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
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.
- Generic labels
- The Upjohn Company's Package Insert
- The Upjohn Company's bottle label
- The Upjohn Company's Carton Label
- 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.