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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-088 Sedazine™ - original approval

Approval Date: February 24, 1994

I. GENERAL INFORMATION:
NADA200-088
Sponsor:Fort Dodge Laboratories
P.O. Box 518
Fort Dodge, Iowa 50501
Generic Name:xylazine hydrochloride
Trade Name:Sedazine™
Marketing Status: 
II. INDICATIONS FOR USE

Sedazine (xylazine) should be used in horses and Cervidaewhen it is desirable to produce a state of sedation accompanied by a shorter period of analgesia.

Horses: Sedazine has been used successfully as follows:

  1. Diagnostic procedures -- oral and opthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations.
  2. Orthopedic procedures, such as application of casting materials and splints.
  3. Dental procedures.
  4. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations.
  5. To calm and facilitate handling of fractious animals.
  6. Therapeutic medication for sedation and relief of pain following injury or surgery.
  7. Major surgical procedures:
    1. When used as a preanesthetic to general anesthesia.
    2. When used in conjunction with local anesthetics.

Cervidae: Sedazine may be used for the following:

To calm and facilitate the handling of fractious animals.

  1. Diagnostic procedures.
  2. Minor surgical procedures.
  3. Therapeutic medication for sedation and relief of pain following injury or surgery.
  4. As a preanesthetic to local anesthesia. Sedazine at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.
III. DOSAGE
A.DOSAGE FORMSolution
B.ROUTE OF ADMINISTRATIONIntravenous and intramuscular (horse)
Intramuscular (Cervidae )
C.RECOMMENDED DOSAGES: 
 HorseIntravenous: 0.5 mL/100 lbs body weight (0.5 mg/lb)
Intramuscular: 1.0 mL/100 lbs body weight (1.0 mg/lb)
 Cervidae

Fallow Deer (Dama dama ): 2.0 to 4.0 mL/100 lbs body weight (2.0 to 4.0 mg/lb).

Mule Deer (Odocoileus hemionus ), Sika Deer (Cervus nippon ) and White-Tailed Deer (Odocoileus virginianus ): 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb)

Elk (Cervus canadensis ): 0.25 to 0.5 mL/100 lbs body weight (0.25 to 0.5 mg/lb)

IV. & V. EFFECTIVENESS AND ANIMAL TARGET:

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 upon the information provided for the generic product, Fort Dodge Laboratories was granted a waiver December 13, 1989 (see section 4) from conducting an in vivo bioequivalence study with xylazine hydrochloride. The generic product is a solution containing the same active and inactive ingredients as the pioneer product. It is intended solely for intravenous and intramuscular injection.

VI. 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 and Cervidaenot intended for food.

Human Safety Relative to Possession, Handling, and Administration:
Labeling contains adequate caution/warning statements.

WAIVER LETTER

GC-1814

John R. Eppley, B.S., D.V.M.
Associate Director, Quality Assurance & Regulatory Affairs
Fort Dodge Laboratories
Fort Dodge, Iowa 50501

Dear Dr. Eppley:

We refer to your letter dated October 17, 1989, regarding a generic copy of Rompun (Xylazine) Injectable for intravenous and intramuscular injection in horses.

You requested a waiver from in vivo bioequivalence testing and submitted information on the components and composition of your proposed product.

Based on the information you provided, your proposed product is a solution containing the same active and inactive ingredients as the pioneer product. It is intended solely for intravenous and intramuscular injection. It is, therefore, eligible for waiver from in vivo bioequivalence testing under our current policy.

Your Request for Waiver is granted. It is granted, however, on the condition that the full information presented in your Abbreviated New Animal Drug Application continues to show that your proposed generic product is chemically equivalent to the pioneer product. If it is not, in vivo bioequivalence testing could be required.

In submitting your ANADA, please refer to the number at the top of this letter and include a copy of this correspondence in your original submission.

Sincerely,

Thomas J. McKay, Ph.D
Generic Animal Drug Staff
Center for Veterinary Medicine

VII. AGENCY CONCLUSIONS:

This ANADA satisfies the requirements of section 512 of the Act and demonstrates that xylazine hydrochloride is safe and effective for its labeled indications when used under its proposed conditions of use.

VIII. LABELING (Attached):

Generic (Sedazine(TM): Fort Dodge Laboratories) photocopies of:

  1. Package insert
  2. Carton for 50 mL vial
  3. Label for 50 mL vial
  4. Shipper carton for 12-50 mL vials
  5. Agency letter granting waiver of bioequivalency testing (December 13, 1986)

Pioneer (Rompun®: Miles, Inc.) photocopies of:

  1. Package insert
  2. Carton for 50 mL vials
  3. Label for 50 mL vial
  4. Shipper carton for 6-50 mL vials

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.