Approval Date: March 14, 1997
I. GENERAL INFORMATION
Phoenix Scientific, Inc.
P.O. Box 6457
St. Joseph, MO 64506-0457
amikacin sulfate, USP
Amikacin Sulfate Injection
Dosage Form: Solution
How Supplied: 50 mL multiple dose vials
How Dispensed: Rx
Amount of Active Ingredients: Each mL contains 50 mg of amikacin (base)
Route of Administration: Subcutaneous or Intramuscular Injection
Labeled Dosage: 10 mg per kg twice daily
Indications for Use:
- For treatment of the following conditions in dogs: Genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus sp.
- Skin and soft tissue infections caused by susceptible strains of Pseudomonas sp. and Escherichia coli.
Pioneer Product: Amiglyde-V® Injection (Amikacin Sulfate 50 mg/mL) manufactured by Fort Dodge Laboratories, Inc. (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 upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver April 13, 1994, from conducting an in vivo bioequivalence study with Amikacin Sulfate Injection. The generic product is administered as a solution, contains the same active ingredient in the same concentration, is a subcutaneous or intramuscular dosage form as is the pioneer product, and contains the same inactive ingredients.
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. This drug is labeled for use in dogs only and should not be administered to food-producing animals.
Human Safety Relative to Possession, Handling and Administration
Labeling contains adequate caution/warning statements.
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 Injection (50 mg/mL), to the pioneer product were established by demonstration of chemical equivalence to the pioneer product, Fort Dodge's Amiglyde-V® Injection (NADA 127-892).
This generic product and the pioneer product have identical labeling indications for the 50 mL vial for use in dogs. The route and method of administration of the two drugs are identical. Both drugs are administered by injection. 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 Injection is safe and effective for its labeled indications when used under its proposed conditions of use.
- Generic Labeling:
- Bottle Label
- Package Insert
- Shipper Carton Label (12 X 50mL)
- Pioneer Labeling (most current):
- Bottle Label
- Package Insert
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