Approval Date: September 11, 1996
Freedom of Information Summary
NADA 200-061
I. GENERAL INFORMATION:
NADA 200-061 Sponsor: AgriLabs
P.O. Box 3103
St. Joseph, MO 64503Generic Name: flunixin meglumine Trade Name: (to be established) Marketing Status: Prescription Amount of Active Ingredients: Each mL contains 50 mg flunixin base.
Route of Administration: Intravenous or intramuscular injection.
Species: Equine.
Labeled Dosage: The recommended dose is 0.5 mg per pound (1 mL/100 lbs.) of body weight once daily for up to five days.
Indications for Use: "Tradename" (flunixin meglumine) Solution is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.
Pioneer Product: Banamine® (flunixin meglumine), manufactured by Schering-Plough Corporation (NADA 101-479).
2. 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, AgriLabs was granted a waiver January 3, 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.
3. 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.
4. 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.
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.
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that flunixin meglumine is safe and effective for its labeled indications when used under its proposed conditions of use.
Attachments:
1. Copy of waiver letter.
2. Generic (FINAL) and Pioneer Labeling (MOST CURRENT).
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