[Federal Register: August 26, 2005 (Volume 70, Number 165)]
[Rules and Regulations]
[Page 50181-50183]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au05-12]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 529
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of New Animal Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations by removing those portions that reflect approval of 16
new animal drug applications (NADAs) and 1 abbreviated NADA (ANADA)
because they are no longer manufactured or marketed. In a notice
published elsewhere in this issue of the Federal Register, FDA is
withdrawing approval of these NADAs.
DATES: This rule is effective September 6, 2005.
FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-7818, e-mail:
pesposit@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the 16 NADAs and 1 ANADA listed in table 1 of
this document because the products are no longer manufactured or
marketed:
Table 1.
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21 CFR Section Affected (Sponsor
Sponsor NADA Number, Product (Drug) Drug Labeler Code)
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Abbott Laboratories, North Chicago, NADA 99-568, FURANACE Caps 529.1526 (000074)
IL 60064 (nifurpirinol)
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Biocraft Laboratories, Inc., 92 NADA 140-889, DERM-OTIC Ointment 524.1600a (000332)
Route 46, Elmwood Park, NJ 07407 (neomycin sulfate; nystatin;
thiostrepton; triamcinolone
acetonide)
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First Priority, Inc., 1585 Todd NADA 48-646, THERAZONE Injection 522.1720 (058829)
Farm Dr., Elgin, IL 60123 (phenylbutazone)
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Happy Jack, Inc., Snow Hill, NC NADA 121-556, Selenium Sulfide 524.2101 (023851)
28580 Suspension (selenium disulfide)
NADA 121-723, Nitrofurazone Dressing 524.1580b (023851)
NADA 125-137, FILARICIDE Capsules 520.622d (023851)
(diethylcarbamazine citrate)
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IMPAX Laboratories, Inc., 30831 NADA 92-151, N-Butyl Chloride Canine 520.260 (000115)
Huntwood Ave., Hayward, CA 94544 Worming Caps
NADA 65-065, Tetracycline HCl Caps 520.2345a (000115)
NADA 138-900, Dichlorophene/Toluene 520.580 (000115)
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Jorgensen Laboratories, Inc., 1450 NADA 10-481, SUREJETS (salicylic 529.2090 (048087)
North Van Buren Ave., Loveland, CO acid)
80538
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Pliva d.d., Ulica grada Vukovara ANADA 200-232, GEOMYCIN 200 Injection 522.1660a (011722)
49, 10000 Zagreb, Croatia (oxytetracycline)
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Purina Mills, Inc., P.O. Box 66812, NADA 65-113 AUREO Sulfa Soluble N/A (017800)
St. Louis, MO 63166-6812 Powder (chlortetracycline/
sulfamethazine)
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Roche Vitamins, Inc., 45 Waterview NADA 140-848, VETEEZE Injection 522.575 (063238)
Blvd., Parsippany, NJ 07054-1298 (diazepam)
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Teva Pharmaceuticals USA, 650 NADA 131-806, Furosemide Tablets 520.1010 (000093)
Cathill Rd., Sellersville, PA
18960
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[[Page 50182]]
Virbac AH, Inc., 3200 Meacham NADA 10-886, Purina Liquid Wormer N/A (051311)
Blvd., Ft. Worth, TX 76137 (piperazine citrate)
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Wyeth Laboratories, Division NADA 10-782, SPARINE Injection 522.1962 (000008)
American Home Products Corp., P.O. (promazine)
Box 8299, Philadelphia, PA 19101
NADA 55-008, BICILLIN Fortified 522.1696a (000008)
(penicillin G benzathine and
penicillin G procaine)
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Following the withdrawal of approval of these NADAs, Biocraft
Laboratories, Inc., IMPAX Laboratories, Inc., Jorgensen Laboratories,
Inc., Pliva d.d., and Teva Pharmaceuticals USA are no longer sponsors
of an approved application. Therefore, we are removing entries for
these five sponsors from 21 CFR 510.600(c).
As provided below, the animal drug regulations are amended to
reflect the withdrawal of approvals and a current format. In addition,
FDA has noticed that the regulations do not reflect approved NADA 065-
063 for Tetracycline Capsules sponsored by Eon Labs Manufacturing, Inc.
At this time, the regulations in 21 CFR 520.2345a are amended to
reflect this approved product.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
0
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, and 529 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
0
2. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entries for ``Biocraft Laboratories, Inc.'', ``IMPAX
Laboratories, Inc.'', ``Jorgensen Laboratories, Inc.'', ``Pliva d.d.'',
and ``Teva Pharmaceuticals USA''; and in the table in paragraph (c)(2)
by removing the entries for ``000093'', ``000115'', ``000332'',
``011722'', and ``045087''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.260 [Amended]
0
4. Section 520.260 is amended in paragraph (b)(2) by removing ``000115
or''; and by removing paragraph (c).
Sec. 520.580 [Amended]
0
5. Section 520.580 is amended in paragraph (b)(1) by removing ``,
000115''.
0
6. Section 520.622d is revised to read as follows:
Sec. 520.622d Diethylcarbamazine citrate capsules.
(a) Specifications. Each capsule contains 12.5, 50, 200, or 400
milligrams (mg) diethylcarbamazine citrate.
(b) Sponsor. See No. 011014 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount/indications for use. 3 mg
per pound (/lb) body weight daily for prevention of heartworm disease
(Dirofilaria immitis); 25 to 50 mg/lb body weight in a single dose as
an aid in the treatment of ascarid infections (Toxocara canis and
Toxascaris leonina).
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.1010 [Amended]
0
7. Section 520.1010 is amended by removing paragraph (b)(2); and by
redesignating paragraphs (b)(3) and (b)(4) as paragraphs (b)(2) and
(b)(3), respectively.
0
8. Section 520.2345a is revised to read as follows
Sec. 520.2345a Tetracycline hydrochloride capsules.
(a) Specifications. Each capsule contains 50, 100, 125, 250, or 500
milligrams (mg) tetracycline hydrochloride.
(b) Sponsor. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section:
(1) No. 000009: 250 mg per capsule.
(2) No. 000069: 125, 250, or 500 mg per capsule.
(3) No. 000185: 50, 100, 250, or 500 mg per capsule.
(c) Conditions of use in dogs--(1) Amount. 25 mg per pound of body
weight per day in divided doses every 6 hours.
(2) Indications for use. For treatment of infections caused by
organisms sensitive to tetracycline hydrochloride, such as bacterial
gastroenteritis due to E. coli and urinary tract infections due to
Staphylococcus spp. and E. coli.
(3)Limitations. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.575 [Removed]
0
10. Section 522.575 is removed.
Sec. 522.1660a [Amended]
0
11. Section 522.1660a is amended in paragraph (b) by removing ``,
011722''.
Sec. 522.1696a [Amended]
0
12. Section 522.1696a is amended in paragraph (b)(1) by removing
``000008,''.
Sec. 522.1720 [Amended]
0
13. Section 522.1720 is amended in paragraph (b)(1) by removing ``,
058829''.
[[Page 50183]]
0
14. Section 522.1962 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 522.1962 Promazine hydrochloride.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section:
(1) No. 000856 for use as in paragraphs (c)(1)(i)(A),
(c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section.
(2) No. 061623 for use as in paragraphs (c)(1)(i)(B),
(c)(1)(ii)(B), and (c)(1)(iii) of this section.
(c) Conditions of use--(1)Horses--(i) Amount--(A) 0.2 to 0.5
milligrams per pounds (mg/lb) body weight intramuscularly or
intravenously every 4 to 6 hours.
(B) 0.2 to 0.5 mg/lb body weight intravenously as required.
(ii) Indications for use--(A) For use as a tranquilizer,
preanesthetic, or for minor operative procedures in conjunction with
local anesthesia; and as adjunctive therapy for tetanus.
(B) For use as a tranquilizer and preanesthetic.
(iii) Limitations. Not for use in horses intended for food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Dogs and cats--(i) Amount. 1 to 2 mg/lb body weight
intramuscularly or intravenously every 4 to 6 hours.
(ii) Indications for use. For use as a tranquilizer, preanesthetic,
for minor operative procedures in conjunction with local anesthesia, as
adjunctive therapy for tetanus, and as an antiemetic prior to worming;
or to prevent motion sickness in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
15. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
16. Section 524.1580b is amended by redesignating paragraph (c) as
paragraph (d); by reserving new paragraph (c); and by revising
paragraph (b) and newly redesignated paragraph (d) to read as follows:
Sec. 524.1580b Nitrofurazone ointment.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) See Nos. 000010, 000069, 050749, 051259, 058005, and 061623 for
use on dogs, cats, or horses.
(2) See No. 017135 for use on dogs and horses.
(c) [Reserved]
(d) Conditions of use--(1) Amount. Apply directly on the lesion
with a spatula or first place on a piece of gauze. The preparation
should remain on the lesion for at least 24 hours. Use of a bandage is
optional.
(2) Indications for use. For prevention or treatment of surface
bacterial infections of wounds, burns, and cutaneous ulcers of dogs,
cats, or horses.
(3) Limitations. For use only on dogs, cats, and horses (not for
food use). In case of deep or puncture wounds or serious burns, use
only as recommended by veterinarian. If redness, irritation, or
swelling persists or increases, discontinue use; consult veterinarian.
Sec. 524.1600a [Amended]
0
17. Section 524.1600a is amended in paragraph (b) by removing ``,
000332''.
0
18. Section 524.2101 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 524.2101 Selenium disulfide suspension.
* * * * *
(b) Sponsors. See Nos. 000061, 017135, and 050604 in Sec.
510.600(c) of this chapter.
(c) Conditions of use on dogs--(1) Indications for use. For use as
a cleansing shampoo and as an agent for removing skin debris associated
with dry eczema, seborrhea, and nonspecific dermatoses.
(2) Amount. One to 2 ounces per application.
(3) Limitations. Use carefully around scrotum and eyes, covering
scrotum with petrolatum. Allow the shampoo to remain for 5 to 15
minutes before thorough rinsing. Repeat treatment once or twice a week.
If conditions persist or if rash or irritation develops, discontinue
use and consult a veterinarian.
PART 529--OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
19. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1526 [Removed]
0
20. Section 529.1526 is removed.
Sec. 529.2090 [Removed]
0
21. Section 529.2090 is removed.
Dated: June 30, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-16995 Filed 8-25-05; 8:45 am]
BILLING CODE 4160-01-S