[Federal Register Volume 59, Number 166 (Monday, August 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21158]


[[Page Unknown]]

[Federal Register: August 29, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

 

Certain Other Dosage Form New Animal Drugs; Isoflurane

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 Inhalon Pharmaceuticals, Inc. The ANADA 
provides for the use of a generic isoflurane for induction and 
maintenance of anesthesia in horses and dogs.

EFFECTIVE DATE: August 29, 1994.

FOR FURTHER INFORMATION CONTACT:
Larry D. Rollins, Center for Veterinary Medicine (HFV-110), Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-
1612.

SUPPLEMENTARY INFORMATION: Inhalon Pharmaceuticals, Inc., P.O. Box 
21170, Lehigh Valley, PA 18002, filed ANADA 200-141, which provides for 
the use of a generic isoflurane (99.9 percent isoflurane solution) for 
induction and maintenance of anesthesia in horses and dogs.
    Inhalon Pharmaceuticals' ANADA 200-141 for isoflurane is approved 
as a generic copy of Anaquest's NADA 135-773 for isoflurane. The ANADA 
is approved as of July 26, 1994, and the regulations are amended in 21 
CFR 529.1186 to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    In addition, Inhalon Pharmaceuticals, Inc., has not previously been 
listed in 21 CFR 510.600 (c)(1) and (c)(2) as sponsor of an approved 
application. 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 529

    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 
529 is 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 
adding alphabetically a new entry for ``Inhalon Pharmaceuticals, Inc.'' 
and in the table in paragraph (c)(2) by adding numerically a new entry 
for ``060307'' to read as follows:


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

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

------------------------------------------------------------------------
                                                                  Drug  
                     Firm name and address                       labeler
                                                                  code  
------------------------------------------------------------------------
                                                                        
                                  *****                                 
Inhalon Pharmaceuticals, Inc., P.O. Box 21170, Lehigh Valley,           
 PA 18002.....................................................    060307
                                                                        
                                  *****                                 
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
 Drug labeler                                                           
     code                        Firm name and address                  
------------------------------------------------------------------------
                                                                        
                                  *****                                 
060307.......  Inhalon Pharmaceuticals, Inc., P.O. Box 21170, Lehigh    
                Valley, PA 18002                                        
                                                                        
                                  *****                                 
------------------------------------------------------------------------

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec. 529.1186  [Amended]

    2. Section 529.1186 Isoflurane is amended in paragraph (b) by 
removing the phrase ``Nos. 010019 and 000074'' and adding in its place 
``Nos. 010019, 000074, and 06037''.

    Dated: August 19, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-21158 Filed 8-26-94; 8:45 am]
BILLING CODE 4160-01-M