[Federal Register Volume 63, Number 84 (Friday, May 1, 1998)]
[Rules and Regulations]
[Pages 24105-24106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11685]


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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 Marsam Pharmaceuticals, Inc. The ANADA 
provides for inhalational use of isoflurane USP for induction and 
maintenance of general anesthesia in horses and dogs.

EFFECTIVE DATE: May 1, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Marsam Pharmaceuticals, Inc., Bldg. 31, 24 
Olney Ave., Cherry Hill, NJ 08034, filed ANADA 200-187 that provides 
for inhalational use of isoflurane USP for induction and maintenance of 
general anesthesia in horses and dogs. The drug is limited to use by or 
on the order of a licensed veterinarian.
    Approval of ANADA 200-187 for Marsam Pharmaceuticals, Inc.'s, 
isoflurane is as a generic copy of Ohmeda Pharmaceutical Product's NADA 
135-773 AErrane (isoflurane, USP). The ANADA is approved as 
of February 11, 1998, and the regulations are amended in 21 CFR 
529.1186(b) to reflect the approval. The basis of approval is discussed 
in the freedom of information summary.
    In addition, Marsam Pharmaceuticals, Inc., has not been previously 
listed in Sec. 510.600 (21 CFR 510.600) as sponsor of an approved 
application. The regulations are amended in Sec. 510.600(c)(1) and 
(c)(2) to reflect the new sponsor.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20855, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(d)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

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 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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


[[Page 24106]]


    Authority: 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 an entry for ``Marsam Pharmaceuticals, Inc.,'' 
and in the table in paragraph (c)(2) by numerically adding an entry for 
``000209'' to read as follows:


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

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

                                                                                                                
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                 Firm name and address                                      Drug labeler code                   
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave.,   000209                                                 
 Cherry Hill, NJ 08034.                                                                                         
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    (2) * * *

                                                                                                                
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                   Drug labeler code                                      Firm name and address                 
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
000209                                                   Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., 
                                                          Cherry Hill, NJ 08034.                                
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

    Authority: 21 U.S.C. 360b.

    2. Section 529.1186 is amended by revising paragraph (b) to read as 
follows:


Sec. 529.1186  Isoflurane.

* * * * *
    (b) Sponsors. See Nos. 000074, 000209, 010019, 012164, and 059258 
in Sec. 510.600(c) of this chapter.
* * * * *

    Dated: April 22, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-11685 Filed 4-30-98; 8:45 am]
BILLING CODE 4160-01-F