Approval Date: July 14, 1998
I. GENERAL INFORMATION
Phoenix Scientific, Inc.
iron Hydrogenated Dextran
iron Dextran Injection (100 mg/mL)
100 mL multiple dose vials
Amount of Active Ingredients:
Each mL contains 100 mg of iron as iron dextran complex/p>
Route of Administration:
Swine (baby pigs)
Intramuscular Injection. Prevention: 1 mL (100 mg) at 2-4 days of age.
Treatment 1 mL (100 mg).
May be repeated in approximately 10 days.
Indications for Use:
For the prevention or treatment of iron deficiency anemia in baby pigs.
Iron Dextran Complex Injection, Boehringer Ingelheim Vetmedica (formerly, Fermenta Animal Health Co.)
II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS
Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. Approval of an ANADA is based on a demonstration that the generic product is bioequivalent to the pioneer. Ordinarily, the ANADA sponsor shows bioequivalence and conducts a tissue residue study to establish the withdrawal time for the generic product. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (Fifth GADPTRA Policy Letter, 55 FR 24645, June18,1990; Bioequivalence Guidance, 1996, 61 FR 26182, May 24, 1996).
Based upon the formulation characteristics of the pioneer and the proposed generic and both having the same source of supply, Phoenix Scientific, Inc. was granted a waiver from conducting an in vivo bioequivalence study for Iron Dextran Injection (100 mg/ml).
III. HUMAN SAFETY
The tolerance established for the pioneer product applies to the generic product. A tolerance has not been established for iron dextran.
When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal time is that previously assigned to the pioneer product. A withdrawal time for iron dextran injection has not been established.
Regulatory Method for Residues
A regulatory analytical method for residues is not required.
Human Safety Relative to Possession, Handling and Administration
Labeling contains adequate caution/warning statements.
IV. AGENCY CONCLUSION
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that Iron Dextran Injection (100 mg/mL) when used under the proposed conditions of use, is safe and effective for its labeled indications.
- generic product labeling
- pioneer product labeling
- Courtesy copy to the sponsor
- HFV-199, ANADA Orig. A0000 M0001[white copy]
- HFV-2 (Special Mailing List)
- HFV-12 (FOI Staff)
- HFV-102 (GADQC Reserve Copy)
- HFV-102 Green Book (NTurner)
- HFA-305 (Dockets Management Branch)
- HFR-SW350 (KAN-DO: District Office Copy)
- ec: CVM RecordsONADE\A200254A0000foi.sum