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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-181 Amikacin Sulfate Solution - original approval

Approval Date: March 18, 1997

I. GENERAL INFORMATION

NADA200-181
Sponsor:Phoenix Scientific, Inc.
3915 S. 48th St. Terrace
P.O. Box 6457
St. Joseph, MO 64506-0457
Generic Name:amikacin sulfate solution, 250 mg/mL
Trade Name:Amikacin Sulfate Solution
Marketing Status:Prescription

Amount of Active Ingredients: Each mL contains 250 mg amikacin sulfate

Route of Administration: For intrauterine use in the horse only

Species: Equine

Labeled Dosage (s): 2 grams (8 mL) of Amikacin Sulfate Solution mixed with 200 mL 0.9% Sodium Chloride Injection, USP aseptically infused into the uterus daily for three consecutive days

Indications for Use: Amikacin Sulfate Solution 250 mg/mL is an antibiotic indicated for the treatment of uterine infections (endometritis, metritis, and pyometra) in mares, when caused by susceptible organisms including E. coli, Pseudomonas sp., and Klebsiella sp.

Pioneer Product:

Amiglyde-V®
Fort Dodge Animal Health
P.O. Box 400
Princeton, NJ 08543-0400
NADA 127-892

 

II. 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). For certain dosage forms, the Agency may grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; fifth GADPTRA Policy Letter). In lieu of in vivo bioequivalence testing, the bioequivalence of the generic product to the pioneer product is based on the demonstrated chemical equivalence to the pioneer product.

Based on the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver from conducting an in vivo bioequivalence study with Amikacin Sulfate Solution. The generic and pioneer products are solutions with the same active and inactive ingredients in the same concentration.

 

III. HUMAN SAFETY

Human Safety Relative to Food Consumption
Regarding consumption of drug residues in food, human safety data were not required for approval of this ANADA. The drug is to be labeled for use in horses that are not intended for food as follows: "Warning: Not for use in horses intended for food."

 

IV. AGENCY CONCLUSIONS

This is an Abbreviated New Animal Drug Application (ANADA) filed under Section 512(b)(2) of the Federal, Food, Drug and Cosmetic (FFD&C) Act.

Bioequivalence of this generic animal drug, Amikacin Sulfate Solution, to the pioneer product was established by demonstration of chemical equivalence to the pioneer product, Fort Dodge Animal Health's Amiglyde-V®, (NADA 127-892).

This generic product and the pioneer product have identical labeling indications for use. The route and method of administration of the two drugs are identical. Both drugs are administered by uterine infusion. The generic and pioneer products are both solutions that contain the same active and inactive ingredients in the same concentrations. Both products have the same pH. Therefore, consistent with FDA policy implementing Section 512(b)(2) of the FFD&C Act, no in vivo bioequivalency studies were necessary or required.

This ANADA satisfies the requirements of section 512 of the Act and demonstrates that Amikacin Sulfate Solution, when used under its proposed conditions of use, is safe and effective for its labeled indications.

Attachments:

  1. Generic Labeling:
    • Package Insert
    • Label for 48 mL bottle
    • Labeling for 12 x 48 mL carton
  2. Pioneer Labeling:
    • Package Insert
    • Label for 48 mL bottle

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

Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855