Approval Date: August 3, 1998
I. GENERAL INFORMATION:
604 W. Thomas Avenue
P.O. Box A
Shenandoah, Iowa 51601
ketamine hydrochloride solution, USP
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)
II. 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.
III. 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.
IV. 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.
- Vial Label
- Package Insert
- Vial Label
- Package Insert