Approval Date: March 28, 1996
Freedom of Information Summary
NADA 101-862
I. GENERAL INFORMATION:
NADA 101-862 Sponsor: Schering-Plough Animal Health
Schering-Plough Corporation
PO Box 529
Kenilworth, New Jersey 07033Generic Name: gentamicin sulfate veterinary Trade Name: GARASOL® Injection Marketing Status: Over the Counter (OTC) Effect of Supplement: This supplement provides for adding the previously approved turkey claims under NADA 47-486 to the labeling of NADA 101-862. The excipients in the formulations are identical, although the quantities are slightly different. II. INDICATIONS FOR USE
III. DOSAGE:For day-old chicks, GARASOL® Injection is indicated for the prevention of early mortality associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa infections susceptible to gentamicin sulfate.
For 1- to 3-day-old turkeys GARASOL® Injection is indicated as an aid in the prevention of early mortality associated with Arizona paracolon susceptible to gentamicin sulfate.
IV. & V. EFFECTIVENESS AND ANIMAL SAFETY:
A. DOSAGE FORM GARASOL® Injection diluted with sterile, physiological saline solutio B. ROUTE OF ADMINISTRATION subcutaneously C. RECOMMENDED DOSAGES: 1 day old Chickens 0.2 mg gentamicin in a 0.2-mL dos 1 to 3 days old Turkeys 1.0 mg gentamicin in a 0.2-mL dose
For effectiveness and animal safety information relative to turkeys, refer to the FOI for GARASOL® Injection (NADA 47-486). The data, summaries and conclusions which support this approval are now filed in NADA 101-862.
For effectiveness and animal safety information relative to chickens, refer to the FOI for GARASOL® Injection (NADA 101-862).
VI. HUMAN SAFETY:
VII. AGENCY CONCLUSIONS:When GARASOL® Injection (50 or 100 mg/mL) is diluted as described in labeling, the concentration of gentamicin is not different, while the concentration of the excipients (non-therapeutic ingredients) are much lower than those concentrations in the 5-mg/mL formulation, as dosed to turkeys. These differences are inconsequential to safety and efficacy. NADA 101-862 contains sufficient information, such that further studies are not required.
For human safety information relative to turkeys, refer to the FOI for GARASOL® Injection (NADA 47-486). The data, summaries, and conclusions which support this approval are now filed in NADA 101-862.
The data submitted in support of this supplement to the NADA satisfy the requirements of Section 512 of the Federal Food, Drug, and Cosmetic Act and support the request to add the claims for GARASOL® Injection (5 mg/mL) approved for turkeys (NADA 47-486) to GARASOL® Injection (50 and 100 mg/mL) approved for chickens (NADA 101-862).
This action will provide for an animal drug to be marketed under the same conditions as a previously approved animal and, therefore, qualifies for categorical exclusion under 21 CFR 25.24(d)(iii). No change in the dose and indications of GARASOL® Injection provided to chickens and turkeys is permitted by this action
The patent has expired, and approval of this supplement does not affect exclusivity.
VIII. LABELING (Attached)
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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 20857Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.