Approval Date: August 17, 1998
I. GENERAL INFORMATION
Phoenix Scientific, Inc.
iron Dextran Complex
iron Dextran Injection-200
100 mL multiple dose vials
Amount of Active Ingredients:
Each mL contains 200 mg of iron as iron dextran complex
Route of Administration:
Indications for Use:
Prevention: 1 mL (200 mg iron) at 1 to 3 days of age.
Treatment: 1 mL (200 mg elemental iron) at the first sign of iron deficiency.
Iron Gard™ 200 (Iron Dextran Complex) Injection, Fermenta Animal Health (now Boehringer Ingelheim Vetmedica) NADA 134-708
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).
Phoenix Scientific, Inc. was granted a waiver (agency letter dated August 22, 1997) from conducting an in vivo bioequivalence study for Iron Dextran Injection-200 (200 mg/mL). The pioneer and the proposed generic have the same source of supply of bulk iron dextran complex. Hence, both contain the same active and inactive ingredients in the same dosage form and concentration.
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-200 (200 mg/mL) when used under the proposed conditions of use, is safe and effective for its labeled indications.
- generic product labeling
- pioneer product labeling