[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Rules and Regulations]
[Pages 50181-50183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16995]


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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: 
[email protected].

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)
----------------------------------------------------------------------------------------------------------------
Abbott Laboratories, North Chicago,  NADA 99-568, FURANACE Caps             529.1526 (000074)
 IL 60064                             (nifurpirinol)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
First Priority, Inc., 1585 Todd      NADA 48-646, THERAZONE Injection       522.1720 (058829)
 Farm Dr., Elgin, IL 60123            (phenylbutazone)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
Jorgensen Laboratories, Inc., 1450   NADA 10-481, SUREJETS (salicylic       529.2090 (048087)
 North Van Buren Ave., Loveland, CO   acid)
 80538
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------

    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