[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
