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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-070 IsoFlo™ - original approval

Approval Date: March 11, 1993

I. GENERAL INFORMATION:
NADA200-070
Sponsor:Abbott Laboratories
Chemical and Agricultural Products Division
1401 Sheridan Road
North Chicago, IL 60064
Generic Name:isoflurane, USP
Trade Name:IsoFlo™
Marketing Status:Prescription

 

II. INDICATIONS FOR USE

IsoFlo (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs.

 

III. DOSAGE
A.DOSAGE FORMIsoFlo (isoflurane, USP) is a clear, colorless, stable liquid containing no additives or chemical stabilizers.
B.ROUTE OF ADMINISTRATIONInhalation.
C.RECOMMENDED DOSAGES: 
 Horses:For induction of anesthesia: Inspired concentrations of 3.0 to 5.0% isoflurane with oxygen, following a barbiturate anesthetic induction, are used to induce surgical anesthesia in the horse.
For maintenance of anesthesia: Surgical levels of anesthesia may be sustained using a 1.5 to 1.8% concentration of isoflurane in oxygen.
 Dogs:For induction of anesthesia: Inspired concentrations of 2.0 to 2.5% isoflurane with oxygen, following a barbiturate anesthetic induction, are used to induce surgical anesthesia in the dog.
For maintenance of anesthesia: Surgical levels of anesthesia may be sustained using 1.5 to 1.8% concentration of isoflurane in oxygen.

 

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). New target animal safety data and drug effectiveness data were not required for approval of this ANADA. This ANADA relies on the target animal safety and drug effectiveness data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. Bioequivalence is usually demonstrated through a clinical end-point study.

For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990). Based upon the formulation characteristics of the generic product, Abbott Laboratories was granted a waiver from conducting an in vivo bioequivalence study for IsoFlo(TM). The generic and pioneer products are liquid anesthetics with the same active and inactive ingredients. The generic and pioneer products also contain the same concentration of active ingredient. This ANADA was granted a waiver October 5, 1992 (see section 5).

 

VI. HUMAN SAFETY:

Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of this ANADA. The drug is to be labeled for use in dogs, which are non-food animals, and only for use in horses that are not to be used for food, and is to be labeled: "Warning: Not for use in horses intended for food."

Human safety relative to possession, handling and administration:
A cautionary statement which pertains to the safety of this drug product for humans is included in the labeling of the drug product, as follows: "Caution: Operating rooms should be provided with adequate ventilation to prevent the accumulation of anesthetic vapors."

 

VII. AGENCY CONCLUSIONS:

This ANADA satisfies the requirements of section 512 of the Act and demonstrates that IsoFlo (isoflurane, USP), when used under its proposed conditions of use, is safe and effective for labeled indications.

WAIVER LETTER:

R. F. Derick Bonewitz, Ph.D.
Manager, Regulatory Affairs
Abbott Laboratories
1401 Sheridan Road
North Chicago, IL 60064-4000

Dear Dr. Bonewitz:

We refer to your Abbreviated New Animal Drug Application (ANADA) dated March 30, 1992 (AOOO), as amended July 17, 1992 (MOO1), for IsoFlo(TM) (isofluorane, USP, liquid), for use in horses and dogs. The inhalation anesthetic is proposed for induction and maintenance of general anesthesia, and is not for use in horses intended for food. The application was submitted based on the generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988. The approved pioneer product is AErrane(TM), manufactured by Anaquest, Inc. (NADA 135-773). For administrative purposes, we have assigned number 200-070 to your ANADA.

In vivo Bioequivalency Waiver Evaluation:
Your product contains the same active ingredient in the same concentration as the pioneer product. The physicochemical characteristics of your product conform to those of the pioneer. Your request for a waiver of in vivo bioequivalency testing is granted.

Future correspondence to your ANADA file regarding this submission should be identified by this submission's correspondence date and our file number, ANADA 200-070 (AOOO).

Should you have any questions or if we may be of any further assistance, please contact Dr. Sandra K. Woods, Chief for Equine and Antimicrobial Drugs Branch. The telephone number is 1-301-295-8617.

Sincerely yours,

Larry D. Rollins, DVM
Acting Director
Division of Drugs for Non-Food Animals
New Animal Drug Evaluation
Center for Veterinary Medicine

Letter dated October 1, 1992

 

VIII. LABELING (Attachments):

Generic (IsoFlo(TM): Abbott Laboratories) Labeling:

  1. Package Insert
  2. Carton for 100 mL bottle (this carton does not exist for pioneer product)
  3. Label for 100 mL bottle

Pioneer (AErrane(TM): Anaqeust) Labeling:

  1. Package Insert
  2. Label for 100 mL bottle
  3. Carton for 6 - 100 mL bottles (this carton does not exist for generic product)

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.