Approval Date: September 25, 1995
I. GENERAL INFORMATION:
Fort Dodge Laboratories
P.O. Box 518
Fort Dodge, Iowa 50501
Flunixin Meglumine Solution
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 grants a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; fifth GADPTRA Policy Letter). In lieu of bioequivalence testing, the safety and efficacy of the generic product are based on the demonstrated chemical equivalence to the pioneer product.
Based on the formulation characteristics of the generic product, Fort Dodge Laboratories was granted a waiver July 6, 1990, (photocopy attached) from conducting an in vivo bioequivalence study with Banamine®. The generic and pioneer products are solutions with the same inactive ingredients and the same concentrations of the active ingredient.
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 horses not intended for food.
Human Safety Relative to Possession, Handling and Administration: Labeling contains adequate caution/warning statements.
IV. AGENCY CONCLUSIONS:
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that "Tradename" (Flunixin Meglumine) is safe and effective for its labeled indications when used under its proposed conditions of use.
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.
Safety and effectiveness for this generic animal drug, "trade name" (flunixin meglumine, 50 mg/mL), were established by demonstration of chemical equivalence to the pioneer product, Schering-Plough Corporation's Banamine®(flunixin meglumine, 50 mg/mL, NADA#101-479).
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 intravenous or intramuscular injection and repeated for up to five days. 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, in compliance with FDA policy promulgated to implement Section 512(b)(2) of the FFD&C Act, no additional safety, efficacy, or in vivo bioequivalency studies were necessary or required.
- Copy of waiver letter.
- Generic (FINAL) and Pioneer Labeling (MOST CURRENT).
- Generic labeling includes the package insert, bottle labels (50 and 100 mL), and the individual carton label (50 and 100 mL).
- Pioneer labeling includes the package insert, bottle and box labels.
- New Revised edition: March, 1994
- Flunixin Meglumine 100 mL multiple dose vial box label.
- Flunixin Meglumine 50 mg/mL package insert.
- Flunixin Meglumine 50 mL multiple dose vial box label.
- Banamine®Flunixin Meglumine 50 mg/mL package insert.
- Banamine®Flunixin Meglumine 250 mL multiple dose vial box label.
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855