Document ID: FDA-2008-N-0039-0016
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron Dextran Complex Injection; Iron Hydrogenated Dextran Injection
Posted Date: 2008-03-10T04:00Z

[Federal Register: March 10, 2008 (Volume 73, Number 47)]
[Rules and Regulations]               
[Page 12634-12635]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr08-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

 
Implantation or Injectable Dosage Form New Animal Drugs; Change 
of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron 
Dextran Complex Injection; Iron Hydrogenated Dextran Injection

AGENCY: Food and Drug Administration, HHS.

[[Page 12635]]

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for two new animal drug 
applications (NADAs) for injectable iron supplements used in baby pigs 
from Boehringer Ingelheim Vetmedica, Inc., to Animal Health 
Pharmaceuticals, LLC. In addition, FDA is taking this opportunity to 
consolidate injectable iron supplements in a single section of the Code 
of Federal Regulations (CFR). This is being done to simplify and 
clarify the regulations.

DATES: This rule is effective March 10, 2008.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, has informed FDA that it 
has transferred ownership of, and all rights and interest in, NADA 106-
772 for Iron-GARD Injection 100 milligrams/milliliter (mg/mL) and NADA 
134-708 for Iron-GARD Injection 200 mg/mL to Animal Health 
Pharmaceuticals, LLC, 1805 Oak Ridge Circle, suite 101, St. Joseph, MO 
64506. Accordingly, the regulations are amended in 21 CFR 522.1182 to 
reflect these changes of sponsorship.
    In addition, FDA is taking this opportunity to consolidate such 
injectable iron supplements in a single section of the CFR. This is 
being done to simplify and clarify the regulations.
    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 in 21 CFR Part 522

    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 part 522 is 
amended as follows:

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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.940  [Removed]

0
2. Remove Sec.  522.940.

Sec.  522.1055  [Removed]

0
3. Remove Sec.  522.1055.

0
4. Revise Sec.  522.1182 to read as follows:

Sec.  522.1182  Iron injection.

    (a) Specifications. See Sec.  510.440 of this chapter. Each 
milliliter (mL) of solution contains the equivalent of:
    (1) 100 milligrams (mg) of elemental iron derived from:
    (i) Ferric hydroxide;
    (ii) Ferric oxide; or
    (iii) Elemental iron.
    (2) 200 mg of elemental iron derived from ferric hydroxide.
    (b) Sponsors and conditions of use. It is used in baby pigs by 
sponsors in Sec.  510.600(c) of this chapter as follows:
    (1) Nos. 059130 and 068718 for use of product described in 
paragraph (a)(1)(i) of this section as follows:
    (i) For prevention of iron deficiency anemia, inject 100 mg (1 mL) 
by intramuscular injection at 2 to 4 days of age.
    (ii) For treatment of iron deficiency anemia, inject 100 mg (1 mL) 
by intramuscular injection. Dosage may be repeated in approximately 10 
days.
    (2) No. 000856 for use of product described in paragraph (a)(1)(i) 
of this section as follows:
    (i) For the prevention of anemia due to iron deficiency, administer 
an initial intramuscular injection of 100 mg at 2 to 4 days of age. 
Dosage may be repeated in 14 to 21 days.
    (ii) For the treatment of anemia due to iron deficiency, administer 
an intramuscular injection of 200 mg.
    (3) Nos. 000061 and 062408 for use of product described in 
paragraph (a)(1)(i) of this section as follows:
    (i) For the prevention of iron deficiency anemia, administer 
intramuscularly an amount of drug containing 100 to 150 mg of elemental 
iron to animals from 1 to 3 days of age.
    (ii) For the treatment of iron deficiency anemia, administer 
intramuscularly an amount of drug containing 100 to 200 mg of elemental 
iron per animal. Dosage may be repeated in 10 days to 2 weeks.
    (4) Nos. 051311 and 053501 for use of product described in 
paragraph (a)(1)(ii) of this section as follows:
    (i) For prevention of iron deficiency anemia, administer 1 mL by 
intramuscular injection at 2 to 5 days of age. Dosage may be repeated 
at 2 weeks of age.
    (ii) For treatment of iron deficiency anemia, administer 1 to 2 mL 
by intramuscular injection at 5 to 28 days of age.
    (5) No. 053501 for use of product described in paragraph 
(a)(1)(iii) of this section as follows:
    (i) For prevention of anemia due to iron deficiency, administer 100 
mg by intramuscular or subcutaneous injection at 2 to 4 days of age.
    (ii) For treatment of anemia due to iron deficiency, administer 100 
mg by intramuscular or subcutaneous injection up to 4 weeks of age.
    (6) Nos. 058005 and 059130 for use of product described in 
paragraph (a)(1)(iii) of this section as follows:
    (i) For prevention of anemia due to iron deficiency, administer 100 
mg by intramuscular injection at 2 to 4 days of age.
    (ii) For treatment of anemia due to iron deficiency, administer 100 
mg by intramuscular injection. Treatment may be repeated in 10 days.
    (7) Nos. 059130 and 068718 for use of product described in 
paragraph (a)(2) of this section as follows:
    (i) For prevention of baby pig anemia due to iron deficiency, 
intramuscularly inject 200 mg of elemental iron (1 mL) at 1 to 3 days 
of age.
    (ii) For treatment of baby pig anemia due to iron deficiency, 
intramuscularly inject 200 mg of elemental iron at the first sign of 
anemia.
    (8) No. 062408 for use of product described in paragraph (a)(2) of 
this section as follows:
    (i) For prevention of iron deficiency anemia, administer 200 mg 
intramuscularly on or before 3 days of age.
    (ii) For treatment of iron deficiency anemia, administer 200 mg 
intramuscularly.

Sec.  522.1183  [Removed]

0
5. Remove Sec.  522.1183.

    Dated: February 27, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-4603 Filed 3-7-08; 8:45 am]

BILLING CODE 4160-01-S