[Federal Register Volume 60, Number 212 (Thursday, November 2, 1995)]
[Rules and Regulations]
[Pages 55657-55660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26986]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 526, 529, and 558


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 the change of sponsor for 62 approved new 
animal drug applications (NADA's) from SmithKline Beecham Animal Health 
to Pfizer, Inc.

EFFECTIVE DATE: November 2, 1995.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: SmithKline Beecham Animal Health, 1600 Paoli 
Pike, West Chester, PA 19360, has informed FDA that it has transferred 
the ownership of, and all rights and interests in, the following 
approved NADA's to Pfizer, Inc., 235 East 42d St., New York, NY 10017.

                                                                        
------------------------------------------------------------------------
             NADA no.                         Drug and species          
------------------------------------------------------------------------
012-437..........................  Trimeprazine Tartrate Prednisolone   
                                    (Temaril-p) Tablets-canine          
013-201..........................  Prochlorperazine Maleate,            
                                    Isopropamide Iodide (Darbazine)     
                                    Spansule Caps No.1-dog              
014-366..........................  Sodium Liothyronine (Cytobin) Tablets-
                                    dog                                 
015-102..........................  Sulfadimethoxine (Albon Tablets)     
                                    Antibacterial-dog and cat           
015-147..........................  Prochlorperazine Edisylate,          
                                    Isopropamide Iodide (Darbazine)     
                                    Injectable-dog and cat              
031-205..........................  Sulfadimethoxine (Albon Agribon 12.5%
                                    Drinking Water Solution)            
                                    Antibacterial-chicken, turkey, and  
                                    cattle                              
031-715..........................  Sulfadimethoxine (Albon Agribon      
                                    Bolus) Antibacterial-cattle         
031-914..........................  Prochlorperazine, Isopropamide Iodide
                                    (Neo-darbazine) Spansule-dog        
032-704..........................  Poloxalene (Bloat Guard) Premix Top  
                                    Dressing-cattle                     
033-760..........................  Poloxalene (Bloat Guard) Drench-     
                                    cattle                              
035-161..........................  Trimeprazine Tartrate Prednisolone   
                                    (Temaril-p) Spansules-dog           
038-281..........................  Poloxalene (Bloat Guard) Liquid Feed-
                                    cattle                              
039-729..........................  Poloxalene (Therabloat) Drench-cattle
041-245..........................  Sulfadimethoxine (Albon Injection-   
                                    40%) Antibacterial-dog, cat, horse, 
                                    and cattle                          
043-785..........................  Sulfadimethoxine (Albon Oral         
                                    Suspension 5%) Antibacterial-dog and
                                    cat                                 
046-285..........................  Sulfadimethoxine (Albon Soluble      
                                    Powder) Antibacterial-cattle,       
                                    chicken, and turkey                 
055-042..........................  Ampicillin Trihydrate (Ampi-tabs)    
                                    Tablets-dog                         
055-069..........................  Benzathine Cloxacillin (Orbenin-dc)  
                                    Intramammary Infusion-cattle        
055-070..........................  Sodium Cloxacillin (Dariclox)        
                                    Intramammary Infusion Lactating-    
                                    cattle                              
055-074..........................  Ampicillin Trihydrate (Ampi-bol)     
                                    Bolus-calves                        
055-078..........................  Amoxicillin (Amoxi-tabs) 50/100/150/ 
                                    200/400 milligrams (mg) Tablets-dog 
055-079..........................  Ampicillin Trihydrate (Ampi-ject)    
                                    Injectable-dog                      
055-080..........................  Amoxicillin (Amoxi-doser) Oral       
                                    Suspension-swine                    
055-081..........................  Amoxicillin (Amoxi-tabs) 50/100 mg   
                                    Tablets-cat                         
055-084..........................  Ampicillin Sodium (Amp-equine)       
                                    Injectable-horse                    
055-085..........................  Amoxicillin Trihydrate (Amoxi-drop)  
                                    Oral Suspension-dog and cat         
055-087..........................  Amoxicillin Trihydrate (Amoxi-bol)   
                                    Bolus-calves                        
055-088..........................  Amoxicillin Trihydrate (Amoxi-sol)   
                                    Oral Soluble Powder-calves          
055-089..........................  Amoxicillin Trihydrate (Amoxi-inject)
                                    Injectable-cattle                   
055-091..........................  Amoxicillin Trihydrate (Amoxi-inject)
                                    Injectable-dog and cat              
055-095..........................  Ticarcillin Disodium (Ticillin)      
                                    Injectable-horse                    
055-099..........................  Amoxicillin Trihydrate Clavulanate   
                                    Potassium (Clavamox Tablets)-dog and
                                    cat                                 
055-100..........................  Amoxicillin Trihydrate (Amoxi-mast)  
                                    Intramammary Infusion-cattle        
055-101..........................  Amoxicillin Trihydrate Clavulanate   
                                    Potassium (Clavamox) Drops Oral     
                                    Suspension-dog and cat              
091-467..........................  Virginiamycin (Stafac 10, 20, 50,    
                                    500) Premix-poultry, swine, and     
                                    turkey                              
091-513..........................  Virginiamycin (Stafac 10/22 20/44 50/
                                    110 500) Premix-poultry, swine      
093-107..........................  Sulfadimethoxine (Albon Sr Sustained 
                                    Release Bolus)-cattle               

[[Page 55658]]
                                                                        
098-431..........................  Tylan 10 (Tylosin) Premix-swine      
100-929..........................  Sulfadimethoxine Ormetoprim (Primor  
                                    Tablets) 100/20, 200/40, 500/100,   
                                    1,000/200 mg-dog                    
104-493..........................  Diethylcarbamazine Citrate           
                                    (Filaribits) Tablets-dog            
108-687..........................  Dexamethasone (Pet-derm III) Tablets-
                                    dog                                 
109-722..........................  Oxibendazole (Anthelcide Eq Equipar) 
                                    Suspension Anthelmintic-horse       
110-048..........................  Albendazole (Valbazen 11.36%) Drench 
                                    Suspension Cattle Anthelmintic-     
                                    cattle                              
111-369..........................  Dexamethasone Sterile Solution       
                                    (Dexamethasone) Injectable-dog, cat,
                                    and horse                           
120-724..........................  Virginiamycin Monensin Roxarsone     
                                    (Stafac Coban 3-nitro)-poultry      
121-042..........................  Oxibendazole (Anthelcide Eq) Paste-  
                                    horse                               
122-481..........................  Virginiamycin Monensin (Stafac 10,   
                                    44, 110, 500 Coban 45) Premix-      
                                    poultry                             
122-608..........................  Virginiamycin Lasalocid (Stafac 22,  
                                    44, 110, 500 Avatec) Premix-poultry 
122-822..........................  Virginiamycin Amprolium plus         
                                    Ethopabate (Stafac 22, 44, 110, 500 
                                    Amprol) Premix-chicken              
125-961..........................  Sodium Chloride, K Phosphate, K      
                                    Citrate, Citric Acid, Glycine,      
                                    Dextrose Powder-calves              
128-070..........................  Albendazole (Valbazen) Paste         
                                    Anthelmintic-cattle                 
128-517..........................  Diethylcarbamazine Citrate (Pet-dec) 
                                    Tablet-dog                          
136-483..........................  Diethylcarbamazine Citrate,          
                                    Oxibendazole (Filaribits Plus)      
                                    Tablet-dog                          
138-828..........................  Virginiamycin Salinomycin (Stafac 10,
                                    20, 50, 500 Bio-cox) Premix         
                                    Coccidiostat-poultry                
138-953..........................  Virginiamycin Salinomycin Roxarsone  
                                    (Stafac Bio-cox 3-nitro) Premix-    
                                    poultry                             
140-839..........................  Mupirocin (Bactoderm) Ointment-dog   
140-857..........................  Luprostiol (Equestrolin) Injectable  
                                    Equine-mare                         
140-862..........................  Detomidine Hydrochloride (Dormosedan)
                                    Equine Injection-mare               
140-879..........................  Nystatin, Neomycin Sulfate,          
                                    Thiostrepton, Triamcinolone         
                                    Acetonide (Derma 4) Ointment-dog and
                                    cat                                 
140-893..........................  Epsiprantel (Cestex) Tablets-dog and 
                                    cat                                 
140-934..........................  Albendazole (Valbazen) Oral          
                                    Suspension Sheep Anthelmintic-sheep 
140-998..........................  Virginiamycin (V-max) Type A         
                                    Medicated Article Feedlot-cattle    
------------------------------------------------------------------------



    The agency is amending 21 CFR 510.600(c)(1) and (c)(2) to remove 
the sponsor name for SmithKline Beecham Animal Health because the firm 
no longer is the holder of any approved NADA's. The agency is also 
amending 21 CFR parts 520, 522, 524, 526, 529, and 558 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, 524, 526, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.
    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, 524, 526, 529, and 558 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 removing the entry for ``SmithKline Beecham Animal Health'' 
and in the table in paragraph (c)(2) by removing the entry for 
``053571''.

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. 520.45a  [Amended]

    4. Section 520.45a Albendazole suspension is amended in paragraph 
(b) by removing ``053571'' and adding in its place ``000069''.


Sec. 520.45b  [Amended]

    5. Section 520.45b Albendazole paste is amended in paragraph (b) by 
removing ``053571'' and adding in its place ``000069''.


Sec. 520.88a  [Amended]

    6. Section 520.88a Amoxicillin trihydrate film-coated tablets is 
amended in paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.88b  [Amended]

    7. Section 522.88b Amoxicillin trihydrate for oral suspension is 
amended in paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.88c  [Amended]

    8. Section 520.88c Amoxicillin trihydrate oral suspension is 
amended in paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.88d  [Amended]

    9. Section 520.88d Amoxicillin trihydrate soluble powder is amended 
in paragraph (b) by removing ``053571'' and adding in its place 
``000069''.

[[Page 55659]]



Sec. 520.88e  [Amended]

    10. Section 520.88e Amoxicillin trihydrate boluses is amended in 
paragraph (b) by removing ``053571'' and adding in its place ``000069'' 
.


Sec. 520.88g  [Amended]

    11. Section 520.88g Amoxicillin trihydrate and clavulanate 
potassium film-coated tablets is amended in paragraph (b) by removing 
``053571'' and adding in its place ``000069''.


Sec. 520.88h  [Amended]

    12. Section 520.88h Amoxicillin trihydrate and clavulanate 
potassium for oral suspension is amended in paragraph (b) by removing 
``053571'' and adding in its place ``000069''.


Sec. 520.90b  [Amended]

    13. Section 520.90b Ampicillin trihydrate tablets is amended in 
paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.90f  [Amended]

    14. Section 520.90f Ampicillin trihydrate boluses is amended in 
paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.540c  [Amended]

    15. Section 520.540c Dexamethasone chewable tablets is amended in 
paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.550  [Amended]

    16. Section 520.550 Dextrose/glycine/electrolyte is amended in 
paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.622c  [Amended]

    17. Section 520.622c Diethylcarbamazine citrate chewable tablets is 
amended in paragraph (b)(2) by removing ``053571'' and adding in its 
place ``000069''.


Sec. 520.623  [Amended]

    18. Section 520.623 Diethylcarbamazine citrate, oxibendazole 
chewable tablets is amended in paragraph (b) by removing ``053571'' and 
adding in its place ``000069''.


Sec. 520.816  [Amended]

    19. Section 520.816 Epsiprantel tablets is amended in paragraph (b) 
by removing ``053571'' and adding in its place ``000069''.


Sec. 520.1284  [Amended]

    20. Section 520.1284 Sodium liothyronine tablets is amended in 
paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.1638  [Amended]

    21. Section 520.1638 Oxibendazole paste is amended in paragraph (b) 
by removing ``053571'' and adding in its place ``000069''.


Sec. 520.1640  [Amended]

    22. Section 520.1640 Oxibendazole suspension is amended in 
paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 520.1840  [Amended]

    23. Section 520.1840 Poloxalene is amended in paragraph (c)(1) and 
(c)(2) by removing ``053571'' and adding in its place ``000069''.


Sec. 520.1920  [Amended]

    24. Section 520.1920 Prochlorperazine, isopropamide sustained 
release capsules is amended in paragraph (b) by removing ``053571'' and 
adding in its place ``000069''.


Sec. 520.1921  [Amended]

    25. Section 520.1921 Prochlorperazine, isopropamide with neomycin 
sustained-release capsules is amended in paragraph (b) by removing 
``053571'' and adding in its place ``000069''.


Sec. 520.2260a  [Amended]

    26. Section 520.2260a Sulfamethazine oblets and boluses is amended 
in paragraph (b)(1) by removing ``053501'' and adding in its place 
``000069''.


Sec. 520.2260b  [Amended]

    27. Section 520.2260b Sulfamethazine sustained-release boluses is 
amended in paragraph (b)(1) by removing ``053501'' and adding in its 
place ``000069''.


Sec. 520.2260c  [Amended]

    28. Section 520.2260c Sulfamethazine sustained-release tablets is 
amended in paragraph (a) by removing ``053501'' and adding in its place 
``000069''.


Sec. 520.2604  [Amended]

    29. Section 520.2604 Trimeprazine tartrate and prednisolone tablets 
is amended in paragraph (b) by removing ``053571'' and adding in its 
place ``000069''.


Sec. 520.2605  [Amended]

    30. Section 520.2605 Trimeprazine tartrate and prednisolone 
capsules is amended in paragraph (b) by removing ``053571'' and adding 
in its place ``000069''.

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

    31. 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. 522.88  [Amended]

    32. Section 522.88 Sterile amoxicillin trihydrate for suspension is 
amended in paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 522.90a  [Amended]

    33. Section 522.90a  Ampicillin trihydrate sterile suspension is 
amended in paragraph (b)(1) by removing ``053571'' and adding in its 
place ``000069''.


Sec. 522.90c  [Amended]

    34. Section 522.90c Ampicillin sodium for aqueous injection is 
amended in paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 522.540  [Amended]

    35. Section 522.540 Dexamethasone injection is amended in paragraph 
(d)(2)(i) by removing ``053571'' and adding in its place ``000069''.


Sec. 522.1290  [Amended]

    36. Section 522.1290 Luprostiol sterile solution is amended in 
paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 522.1920  [Amended]

    37. Section 522.1920 Prochlorperazine, isopropamide for injection 
is amended in paragraph (b) by removing ``053571'' and adding in its 
place ``000069''.

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

    38. 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. 524.1005  [Amended]

    39. Section 524.1005 Furazolidone aerosol powder is amended in 
paragraph (b)(1) by removing ``053501'' and adding in its place 
``000069''.


Sec. 524.1465  [Amended]

    40. Section 524.1465 Mupirocin ointment is amended in paragraph (b) 
by removing ``053571'' and adding in its place ``000069''.


Sec. 524.1580b  [Amended]

    41. Section 524.1580b Nitrofurazone ointment is amended in 
paragraph (b) by removing ``053571'' and adding in its place 
``000069''.


Sec. 524.1580c  [Amended]

    42. Section 524.1580c Nitrofurazone soluble powder is amended in 
paragraph 

[[Page 55660]]
(b) by removing ``053571'' and adding in its place ``000069''.


Sec. 524.1600a  [Amended]

    43. Section 524.1600a Nystatin, neomycin, thiostrepton, and 
triamcinolone acetonide ointment is amended in paragraph (b) by 
removing ``053571'' and adding in its place ``000069''.

PART 526--INTRAMAMMARY DOSAGE FORMS

    44. The authority citation for 21 CFR part 526 continues to read as 
follows:

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


Sec. 526.88  [Amended]

    45. Section 526.88 Amoxicillin trihydrate for intramammary infusion 
is amended in paragraph (b) by removing ``05371'' and adding in its 
place ``000069''.


Sec. 526.464a  [Amended]

    46. Section 526.464a Cloxacillin benzathine for intramammary 
infusion is amended in paragraph (d) by removing ``053571'' and adding 
in its place ``000069''.


Sec. 526.464b  [Amended]

    47. Section 526.464b Cloxacillin benzathine for intramammary 
infusion, sterile is amended in paragraph (d) by removing ``053571'' 
and adding in its place ``000069''.


Sec. 526.464c  [Amended]

    48. Section 526.464c Cloxacillin sodium for intramammary infusion, 
sterile is amended in paragraph (b) by removing ``053571'' and adding 
in its place ``000069''.


Sec. 526.464d  [Amended]

    49. Section 526.464d Cloxacillin sodium for intramammary infusion 
is amended in paragraph (b) by removing ``053571'' and adding in its 
place ``000069''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    50. 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. 529.2464  [Amended]

    51. Section 529.2464 Ticarcillin powder is amended in paragraph (b) 
by removing ``053571'' and adding in its place ``000069''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    52. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).


Sec. 558.464  [Amended]

    53. Section 558.464 Poloxalene is amended in paragraph (a)(1) and 
(a)(2) by removing ``053571'' and adding in its place ``000069''.


Sec. 558.465  [Amended]

    54. Section 558.465 Poloxalene free-choice liquid Type C feed is 
amended in paragraph (a) by removing ``053571'' and adding in its place 
``000069''.


Sec. 558.635  [Amended]

    55. Section 558.635 Virginiamycin is amended in paragraph (b)(1) by 
removing ``053571'' and adding in its place ``000069''.

    Dated: October 24, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 95-26986 Filed 11-1-95; 8:45 am]
BILLING CODE 4160-01-F