[Federal Register Volume 61, Number 30 (Tuesday, February 13, 1996)]
[Rules and Regulations]
[Pages 5505-5507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3078]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 524


Animal Drugs, Feeds, and Related Products; Change of Sponsor

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 a change of sponsor for 35 approved new 
animal drug applications (NADA's) from Syntex Animal Health, Division 
of Syntex Agri-business, Inc., to Fort Dodge Laboratories, Division of 
American Home Products.

EFFECTIVE DATE: February 13, 1996.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Syntex Animal Health, Division of Syntex 
Agri-business, Inc., 3401 Hillview Ave., Palo Alto, CA 94303, has 
informed FDA that it has transferred the ownership of, and all rights 
and interests in, the following approved NADA's to Fort Dodge 
Laboratories, Division of American Home Products Corp., 800 Fifth St. 
NW., Fort Dodge, IA 50501:

                                                                                                                
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        NADA No.                                                 Drug Name                                      
----------------------------------------------------------------------------------------------------------------
9-576...................  Synovex S and Synovex C Implants (progesterone and estradiol      
                           benzoate)                                                                            
11-427..................  Synovex H Implants (testosterone propionate and estradiol benzoate)         
15-126..................  Spectinomycin Injectable & Tablets (spectinomycin)                                    
30-414..................  Flucort (V Solution (flumethasone)                                          
30-415..................  Flucort Tablets (flumethasone)                                              
32-168..................  DOMOSO Solution (dimethyl sulfoxide)                                        
36-211..................  Anaprime Suspension (flumethasone)                                          
36-212..................  Fluosmin Suspension (flumethasone acetate)                                  
37-586..................  Erythromast '36' Solution (erythromycin)                                    
38-801..................  Anaprime Ophthalmic Solution (flumethasone)                                 
41-629..................  Spectinomycin Oral Solution and Spectogard Oral Solution          
                           (spectinomycin)                                                                      
41-665..................  Tranvet Chewable Tablets (propiopromazine hydrochloride)                    
45-512..................  Synotic Otic Solution (fluocinolone acetonide and dimethyl sulfoxide)       
45-716..................  Tranvet Injectable Solution (propiopromazine hydrochloride)                 
47-334..................  Synsac Solution (flucinolone acetonide and dimethyl sulfoxide)              
47-925..................  DOMOSO Gel (dimethyl sulfoxide)                                             
49-725..................  Anaprime Opthakote Ophthalmic Solution (flumethasone with neomycin
                           sulfate and polymyxin B sulfate)                                                     

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49-726..................  Optiprime Opthakote Ophthalmic Solution (neomycin sulfate and     
                           polymyxin B sulfate)                                                                 
96-674..................  Equiproxen Granules (naproxen)                                              
96-675..................  Equiproxen Injectable (naproxen)                                            
100-254.................  Synchrocept (prostalene)                                                    
110-776.................  Benzelmin Powder for Suspension (oxfendazole)                               
110-777.................  Benzelmin Top Dress Pellets (oxfendazole)                                   
115-578.................  Di-Trim Tablets (trimethoprim and sulfadiazine)                             
128-549.................  Bovilene Sterile Solution (fenprostalene)                                   
128-967.................  Repose (sodium secobarbital and dibucaine hydrochloride)                    
132-105.................  Benzelmin 37.5% Paste (oxfendazole)                                         
132-486.................  Di-Trim 24% Injection (trimethoprim and sulfadiazine)                       
133-841.................  Benzelmin 9.06% Suspension (oxfendazole)                                    
134-778.................  Di-Trim 48% Injection (trimethoprim and sulfadiazine)                       
136-342.................  Di-Trim 400 Oral Paste (trimethoprim and sulfadiazine)                      
136-740.................  Benzelmin Plus Paste (oxfendazole plus trichlorfon)                         
138-903.................  Porcilene Sterile Solution (fenprostalene)                                  
140-854.................  Synanthic 9.06% and 22.5% Suspension(oxfendazole)                           
140-892.................  Synanthic 18.5% Paste (oxfendazole)                                         
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    Accordingly, the agency is amending 21 CFR parts 510, 520, 522, and 
524 to reflect the change of sponsor.

List of Subjects

 21 CFR Part 510

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

 21 CFR Parts 520, 522, and 524

     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, 522, and 524 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).

Sec. 510.600   [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 revising the entry for ``Fort Dodge Laboratories'' to read 
``Fort Dodge Laboratories, Division of American Home Products Corp., 
800 Fifth St. NW., Fort Dodge, IA 50501''; and in the table in 
paragraph (c)(2) in the entry for ``000856'' by revising the sponsor 
name and address to read, ``Fort Dodge Laboratories, Division of 
American Home Products, 800 Fifth St. NW., Fort Dodge, IA 50501.''

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. 520.960  [Amended]

    4. Section 520.960 Flumethasone tablets is amended in paragraph (b) 
by removing ``000033'' and adding in its place ``000856''.


Sec. 520.1468  [Amended]

    5. Section 520.1468 Naproxen granules is amended in paragraph (b) 
by removing ``000033'' and adding in its place ``000856''.


Sec. 520.1628  [Amended]

    6. Section 520.1628 Oxfendazole powder and pellets is amended in 
paragraph (b) by removing ``000033'' and adding in its place 
``000856''.


Sec. 520.1629  [Amended]

    7. Section 520.1629 Oxfendazole paste is amended in paragraph 
(a)(2) and (b)(2) by removing ``000033'' and adding in its place 
``000856''.


Sec. 520.1630  [Amended]

    8. Section 520.1630 Oxfendazole suspension is amended in paragraph 
(b) by removing ``000033'' and adding in its place ``000856''.


Sec. 520.1631  [Amended]

    9. Section 520.1631 Oxfendazole and trichlorfon paste is amended in 
paragraph (b) by removing ``000033'' and adding in its place 
``000856''.


Sec. 520.2002  [Amended]

    10. Section 520.2002 Propiopromazine hydrochloride is amended in 
paragraph (c) by removing ``000033'' and adding in its place 
``000856''.


Sec. 520.2122  [Amended]

    11. Section 520.2122 Spectinomycin dihydrochloride oral solution  
is amended in paragraph (b)(2) by removing ``000033'' and adding in its 
place ``000856''.


Sec. 520.2610  [Amended]

    12. Section 520.2610 Trimethoprim and sulfadiazine tablets is 
amended in paragraph (b) by removing ``000033'' and adding in its place 
``000856''.


Sec. 520.2611  [Amended]

    13. Section 520.2611 Trimethoprim and sulfadiazine oral paste is 
amended in paragraph (b) by removing ``000033'' and adding in its place 
``000856''.

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

    14. 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. 522.842  [Amended]

    15. Section 522.842 Estradiol benzoate and testosterone propionate 
in combination is amended in paragraph (b) by removing ``000033'' and 
adding in its place ``000856''.


Sec. 522.914  [Amended]

    16. Section 522.914 Fenprostalene solution is amended in paragraph 
(b) by removing ``000033'' and adding in its place ``000856''.


Sec. 522.960a  [Amended]

    17. Section 522.960a Flumethasone suspension is amended in 
paragraph (c) 

[[Page 5507]]
by removing ``000033'' and adding in its place ``000856''.


Sec. 522.960b  [Amended]

    18. Section 522.960b Flumethasone acetate injection is amended in 
paragraph (c) by removing ``000033'' and adding in its place 
``000856''.


Sec. 522.960c  [Amended]

    19. Section 522.960c Flumethasone solution is amended in paragraph 
(b) by removing ``000033'' and adding in its place ``000856''.


Sec. 522.1468  [Amended]

    20. Section 522.1468 Naproxen for injection is amended in paragraph 
(b) by removing ``000033'' and adding in its place ``000856''.


Sec. 522.1940  [Amended]

    21. Section 522.1940 Progesterone and estradiol benzoate in 
combination is amended in paragraph (b) and (d)(1)(iii) by removing 
``000033'' and adding in its place ``000856''.


Sec. 522.2002  [Amended]

    22. Section 522.2002 Propiopromazine hydrochloride injection is 
amended in paragraph (c) by removing ``000033'' and adding in its place 
``000856''.


Sec. 522.2012  [Amended]

    23. Section 522.2012 Prostalene solution is amended in paragraph 
(b) by removing ``000033'' and adding in its place ``000856''.


Sec. 522.2120  [Amended]

    24. Section 522.2120 Spectinomycin injection is amended in 
paragraph (b) by removing ``000033'' and adding in its place 
``000856''.


Sec. 522.2610  [Amended]

    25. Section 522.2610 Trimethoprim and sulfadiazine sterile 
suspension is amended in paragraph (a)(2) and (b)(2) by removing 
``000033'' and adding in its place ``000856''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    26. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec. 524.660a  [Amended]

    27. Section 524.660a Dimethyl sulfoxide solution is amended in 
paragraph (b) by removing ``000033'' and adding in its place 
``000856''.


Sec. 524.660b  [Amended]

    28. Section 524.660b Dimethyl sulfoxide gel is amended in paragraph 
(b) by removing ``000033'' and adding in its place ``000856''.


Sec. 524.960  [Amended]

    29. Section 524.960 Flumethasone, neomycin sulfate, and polymyxin B 
sulfate ophthalmic solutions is amended in paragraph (b) by removing 
``000033'' and adding in its place ``000856''.


Sec. 524.981d  [Amended]

    30. Section 524.981d Fluocinolone acetonide, dimethyl sulfoxide 
solution is amended in paragraph (b) by removing ``000033'' and adding 
in its place ``000856''.


Sec. 524.1484e  [Amended]

    31. Section 524.1484e Neomycin sulfate and polymyxin B sulfate 
ophthalmic solution is amended in paragraph (b) by removing ``000033'' 
and adding in its place ``000856''.

    Dated: February 1, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-3078 Filed 2-12-96; 8:45 am]
BILLING CODE 4160-01-F