Animal & Veterinary
ANADA 200-124 Flunixin Meglumine Solution - original approval
Approval Date: September 25, 1995
I. GENERAL INFORMATION:
|Sponsor:||Phoenix Scientific, Inc.|
P.O. Box 6457
St. Joseph, MO 64506-0457
|Generic Name:||flunixin meglumine solution|
|Trade Name:||Flunixin Meglumine Solution|
II. INDICATIONS FOR USE
For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.
|B.||ROUTE OF ADMINISTRATION||Intravenous or Intramuscular Injection|
|C.||RECOMMENDED DOSAGES:||0.5 mg/lb body weight (1 mL/100 lbs) once daily|
IV. & V. EFFECTIVENESS AND ANIMAL SAFETY:
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 bioequivalence testing, the safety and efficacy of the generic product are 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 15, 1992, (see Section 5) from conducting an in vivo bioequivalence study with Flunixin Meglumine Injection. The generic and pioneer products are solutions with the same inactive ingredients and the same concentrations of the active ingredient.
V. 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.
Mr. Kevin M. Schinze
Phoenix Scientific, Inc.
3915 S. 48th St. Terrace
P. O. Box 6457
St. Joseph, Missouri 64506-0457
Dear Mr. Schinze:
We refer to your submission dated February 25, 1992, to the Investigational New Animal Drug (INAD) file for a generic copy of Schering's Banamine (flunixin meglumine, 50 mg/mL, NADA 101-479). The product is recommended for the aleviation of inflammation and pain associated with musculoskeletal disorders in the horse. You requested a waiver of the requirement for an in vivo bioequivalence study to support the filing of an Abbreviated New Animal Drug Application (ANADA) based on the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988.
Based on the information you provided, your proposed product is a solution containing the same active and inactive ingredients in the same concentrations as the approved pioneer product. The pH of your product conforms to that of the pioneer. It is, therefore, eligible for a waiver from in vivo bioequivalence testing under our current policy.
Your request for a waiver is granted on the condition that the full information presented in your ANADA continues to show that your proposed generic product is chemically equivalent to the pioneer product. If it is not shown to be chemically equivalent, in vivo bioequialence testing could be required.
Granting of this waiver does not assure approval of your ANADA. All necessary requiremnets must be fulfilled, including certification that your product or its proposed uses do not violate or infringe upon any patent or exclusivity for the pioneer product or its uses.
Future correspondence to your INAD file regarding this submission should be identified by the date of this letter and our file number, INAD 8412-C001.
In submitting your ANADA, please refer to this number and include a copy of this correspondence in your original submission.
Your request for a waiver of the bioequivalency test was reviewed under the National Environmental Policy Act (NEPA). Since no investigation is planned under your INAD, not wastes are expected to enter the environment. Therefore, we have determined that this action qualifies for a categorical exclusion from the requirement to prepare a environmental assessment (EA) under 21 CFR 25.24(d)(4). If studies are planned to be conducted under this INAD, please file either a claim for an exclusion or submit an EA.
All ANADAs require an abbreviated EA. Guidance is available on the preparation of the EA in the Center's second generic animal drug policy letter dated June 7, 1989. The letter contains an example format for preparing an EA for submission to the ANADA.
Contents of an INAD are to be submitted in triplicate (including the cover letter) [21 CFR 511.1(b)(4)].
Should your have questions or need further assistance, please contact Dr. Sandra K. Woods, Chief of Equine & Antimicrobial Drugs Branch. The telephone number is (301) 295-8617.
Bob G. Griffith, DVM
Director, Division of Therapeutic
Drugs for Non-Food Animals
New Animal Drug Evaluation
Center for Veterinary Medicine
VI. 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, Flunixin Meglumine, 50 mg/mL, were established by demonstration of chemical equivalence to the pioneer product, Schering-Plough Animal Health Corporation's Banamine® Solution (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. 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.
VII. LABELING (Attached)
- Copy of waiver letter.
- Generic Labeling:
- Individual Bottle Carton
- Bottle Label
- Package Insert
- Shipper Carton Label
- Pioneer Labeling (most current):
- Individual Bottle Carton
- Bottle Label
- Package Insert
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 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.