Summary of 
FDA Information:
FREEDOM OF INFORMATION SUMMARY

 

1. GENERAL INFORMATION: 

ANADA: 200-055

Sponsor: Lloyd Incorporated
604 W.
Thomas Avenue
P.O. Box A
Shenandoah, Iowa 51601

Drug Labeler Code: 061690
Generic Name: ketamine hydrochloride solution, USP

Trade Name: VetaKet TM

Dosage Form: Injectable solution

How Supplied: 10 mL vials

How Dispensed: Rx

Amount of 
Active
Ingredients: 100 mg ketamine hydrochloride per mL

Route of 
Administration: Intramuscular injection

Species: Cats and 
subhuman primates

Labeled Dosage: 
Cats: A dose of 
11 mg/kg (5 mg/lb) is recommended to produce restraint. Dosages from 
22 to 33 mg/kg (10 to 15 mg/lb) produce anesthesia that is suitable for 
diagnostic or 
minor surgical procedures that do not require skeletal muscle relaxation.

Subhuman Primates: The dose varies from 
3 to 15 mg/kg, depending on the species. See the labeling for 
the exact dose by species. Additional doses for 
other subhuman primate species are listed on the label under 
the CLINICAL STUDIES heading.

Indications for 
Use:

VetaKetTM may be used in cats for 
restraint or 
as the sole anesthetic agent for 
diagnostic or 
minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for 
restraint.

Pioneer Product/ 
Listed Product: Vetalar® (NADA 045-290, Fort Dodge Laboratories) 

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). New target animal safety data, drug effectiveness data, and 

human food safety data (other than tissue residue data) are not required for 
approval of an ANADA. An ANADA relies on bioeqivalence with the pioneer product to demonstrate target animal safety, drug effectiveness, and 

human safety. 

Ordinarily, the 
ANADA sponsor shows that the 
generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study 
, then a tissue residue study 
to establish the withdrawal time for 
the generic product is also required. For certain dosage forms, the 
agency will grant a waiver from 
conducting an in vivo bioequivalence study 
(Fifth GADPTRA Policy Letter: 55 FR 24645, June 18, 1990; Bioequivalence Guidance: 61 FR 26182 - 26186, May 24, 1996).

Based upon the formulation characteristics of 
the generic product, Lloyd Incorporated was 
granted a waiver from 
conducting an in vivo bioequivalence study 
forVetaKetTM.
The generic and 
pioneer products contain the same active and 
inactive ingredients and 
are injectable solutions.
 

3. HUMAN SAFETY:

Human Safety Relative to Food Consumption:

None required as VetaKetTM Liquid is intended for 
use only in cats and 
subhuman primates.
The labeling includes the statement, "For Intramuscular use in Cats and 
Subhuman Primates Only".

Human Safety Relative to Possession, Handling, and 

Administration:

Labeling contains adequate caution/warning statements.
 

4. AGENCY CONCLUSIONS:

This ANADA submitted under 
section 512(b) of 
the Federal Food, Drug and 
Cosmetic Act satisfies the requirements of 
section 512(n) of 
the Act and 
demonstrates that VetaketTM (ketamine hydrochloride injection, USP), when 
used under 
the proposed conditions of 
use, is safe and 
effective for 
the labeled indications.

Attachments:
1. 

Generic Labeling:
Vial Label

Package Insert

2. Pioneer Labeling

Vial Label
Carton 
Package Insert
 

updated 10/23/98 by swd