Approval Date: August 6, 1985
I. GENERAL INFORMATION
Veterinary Laboratories, Inc.
12340 Santa Fe Drive
Lenexa, Kansas 66215
iron hydrogenated dextran injection
Iron Hydrogenated Dextran Injection
Over the Counter (OTC)
II. INDICATIONS FOR USE
For the prevention and treatment of anemia due to iron deficiency in baby pigs.
A. DOSAGE FORM: Injectable solution, contains Iron Hydrogenated Dextran Injection equivalent to 100 mg elemental iron per milliliter.
B. ROUTE OF ADMINISTRATION: Intramuscular
C. RECOMMENDED DOSAGES:
- Prevention: 1 mL (100 mg iron) at 2 to 4 days of age.
- Treatment: 1 mL (100 mg iron). Treatment may be repeated in 10 days.
IV. & V. EFFECTIVENESS AND ANIMAL SAFETY
An Iron Hydrogenated Dextran Injection (Number 8, Rubrafer Improved®) was reviewed by the National Academy of Sciences-National Research Council, Drug Efficacy Study Group, which concluded that the product was safe and effective for the prevention and treatment of iron-deficiency anemia in pigs. The Food and Drug Administration concurred with the conclusions of the Academy (NAS/NRC DESI, 34 FR 2211, February 14, 1969) and subsequently codified the product by regulation (21 CFR 522.1183). Iron Hydrogenated Dextran Injection by Veterinary Laboratories, Inc. is manufactured from bulk Iron Hydrogenated Dextran Injection supplied by Chemdex, Inc., 3200 North 29th Avenue, Hollywood, Florida 33020.
Rubrafer Improved® was also manufactured from bulk Iron Hydrogenated Dextran Injection supplied by Chemdex, Inc. at the time of the NAS/NRC review. Thus, the determination that Iron Hydrogenated Dextran Injection manufactured by Veterinary Laboratories, Inc. is the same as the NAS/NRC - reviewed product is based principally on both having the same source of supply of bulk drug.
VI. HUMAN SAFETY
The Food and Drug Administration has determined that there is no human safety concern for residues resulting from the use of Iron Hydrogenated Dextran Injection in swine under the regulated conditions of use.
VII. AGENCY CONCLUSIONS
- The data submitted in support of this NADA comply with Section 512 of the Act and show that Iron Hydrogenated Dextran Complex when used under its proposed conditions of use is safe and effective for the prevention and treatment of anemia due to iron deficiency in baby pigs.
- The product is OTC. All related products listed under 21 CFR 522.1182 and 522.1183 are OTC, since it is given as a common production practice to all neonatal swine in confinement. Adequate directions for use are on the labeling.
VIII. LABELING (Attached)
- Bottle label
- Package insert
Copies of these labels may be obtained by writing to the:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857