[Federal Register Volume 60, Number 238 (Tuesday, December 12, 1995)]
[Rules and Regulations]
[Pages 63621-63622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30123]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510, 520, and 522


Animal Drugs, Feeds, and Related Products; Diphenylhydantoin 
Sodium Capsules, et al.

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 remove those portions of the regulations that 
reflect approval of one new animal drug application (NADA) held by 
Parke-Davis, Division of Warner-Lambert Co., three held by Akorn, Inc., 
and one held by Veterinary Research and Development, Inc. All of the 
sponsors submitted written requests that the agency withdraw approval 
of the NADA's. In a notice published elsewhere in this issue of the 
Federal Register, FDA is withdrawing approval of the NADA's.

EFFECTIVE DATE: December 22, 1995.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159.

SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of the 
following NADA's:


                                                                        
------------------------------------------------------------------------
                                                       Sponsor name and 
            NADA No.                  Drug name             address     
------------------------------------------------------------------------
6-032..........................  Diphenylhydantoin    Parke-Davis,      
                                  sodium capsules.     Division of      
                                                       Warner-Lambert   
                                                       Co., 201 Tabor   
                                                       Rd., Morris      
                                                       Plains, NJ 07950 
12-444.........................  Sterile              Akorn, Inc., 100  
                                  prednisolone         Akorn Dr., Abita 
                                  suspension.          Springs, LA 70420
94-978.........................  Phenylbutazone       Do.               
                                  injection.                            
110-046........................  Dexamethasone        Do.               
                                  injection.                            
140-904........................  Copper disodium      Veterinary        
                                  edetate injection.   Research and     
                                                       Development,     
                                                       Inc., P.O. Box   
                                                       1299, Truckee, CA
                                                       95734            
------------------------------------------------------------------------


[[Page 63622]]

    The sponsors requested withdrawal of approval of the NADA's because 
the drug products are no longer being marketed. This final rule removes 
21 CFR 520.704, 522.514, and 522.1880, and amends 21 CFR 522.540 and 
522.1720 to reflect the withdrawal of approval of these NADA's.
    In addition, 21 CFR 510.600(c) is amended to remove the entries for 
the three sponsors from the list of approved drug sponsors because they 
no longer hold any approved NADA's.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520 and 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, 
520, 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).

  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entries for ``Akorn, Inc.,'' ``Parke-Davis, 
Division of Warner-Lambert Co.,'' and ``Veterinary Research and 
Development, Inc.'' and in the table in paragraph (c)(2) by removing 
the entries for ``000071,'' ``017478,'' and ``057428.''

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. 520.704   [Removed]

    4. Section 520.704 Diphenylhydantoin sodium capsules is removed.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    5. 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).


Sec. 522.514  [Removed]

    6. Section 522.514 Copper disodium edetate injection is removed.


Sec. 522.540  [Amended]

    7. Section 522.540 Dexamethasone injection is amended by removing 
paragraph (d)(2)(ii) and by redesignating paragraph (d)(2)(iii) as 
paragraph (d)(2)(ii).


Sec. 522.1720  [Amended]

    8. Section 522.1720 Phenylbutazone injection is amended in 
paragraph (b)(1) by removing the phrase ``000031, 017220, 015579, and 
017478'' and adding in its place ``000031, 017220, and 015579''.


Sec. 522.1880  [Removed]

    9. Section 522.1880 Sterile prednisolone suspension is removed.

    Dated: December 4, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-30123 Filed 12-11-95; 8:45 am]
BILLING CODE 4160-01-F