[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19933]


[[Page Unknown]]

[Federal Register: August 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

 

Animal Drugs, Feeds, and Related Products; Ketamine Hydrochloride 
Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Phoenix Pharmaceutical, Inc. The ANADA 
provides for intramuscular use of ketamine hydrochloride injection in 
cats for restraint or as the sole anesthetic agent for diagnostic or 
minor, brief, surgical procedures that do not require skeletal muscle 
relaxation, and in subhuman primates for restraint.

EFFECTIVE DATE: August 15, 1994.

FOR FURTHER INFORMATION CONTACT: Charles W. Francis, Center For 
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: Phoenix Pharmaceutical, Inc., 4621 Easton 
Rd., P.O. Box 6457 Farleigh Station, St. Joseph, MO 64506-0457, filed 
ANADA 200-042. The ANADA provides for intramuscular use of 
Ketaject (ketamine hydrochloride injection, U.S.P.) in cats 
for restraint or as the sole anesthetic agent for diagnostic or minor, 
brief, surgical procedures that do not require skeletal muscle 
relaxation, and in subhuman primates for restraint. The drug is limited 
to use by or on the order of a licensed veterinarian.
    Approval of ANADA 200-042 for Phoenix's Ketaject 
Injection is as a generic copy of Fort Dodge's NADA 045-290 for 
Vetalar/Ketaset (ketamine hydrochloride injection, 
U.S.P.). The ANADA is approved as of June 30, 1994, and the regulations 
in 21 CFR 522.1222a(c) are amended to reflect the approval. The basis 
for approval is discussed in the freedom of information summary.
    In addition, Phoenix Pharmaceutical, Inc., has not been previously 
listed in 21 CFR 510.600(c) as a sponsor of an approved application. 
Accordingly, that section is amended to add entries for the firm.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a 
summary of safety and effectiveness data and information submitted to 
support approval of this application may be seen in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 
522 are amended as follows:

PART 510-- NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority:  Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Phoenix Pharmaceutical, Inc.,'' 
and in the table in paragraph (c)(2) by numerically adding a new entry 
for ``057319'' to read as follows:

Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                            Drug labeler
                   Firm name and address                        code    
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                                  *****                                 
Phoenix Pharmaceutical, Inc., 4621 Easton Rd., P.O. Box                 
 6457 Farleigh Station, St. Joseph, MO 64506-0457.........       057319 
                                  *****                                 
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    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
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                                  *****                                 
                  057319..........  Phoenix Pharmaceutical, Inc., 4621  
                                     Easton Rd., P.O. Box 6457 Farleigh 
                                     Station, St. Joseph, MO 64506-0457 
                                  *****                                 
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 522.1222a is amended by revising paragraph (c) to read 
as follows:

Sec. 522.1222a  Ketamine hydrochloride injection.

* * * * *
    (c) Sponsors. See Nos. 000856 and 057319 in Sec. 510.600(c) of this 
chapter.
* * * * *

    Dated: August 8, 1994.
Richard H. Teske,
Deputy Director, Premarket Review, Center for Veterinary Medicine.
[FR Doc. 94-19933 Filed 8-12-94; 8:45 am]
BILLING CODE 4160-01-F