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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-254 Iron Dextran Injection (100 mg/mL) - original approval

Approval Date: July 14, 1998

I. GENERAL INFORMATION

NADA:200-254
Sponsor:Phoenix Scientific, Inc.
Generic Name:iron Hydrogenated Dextran
Trade Name:iron Dextran Injection (100 mg/mL)
Marketing Status: 
Dosage Form:Sterile Injection
How Supplied:100 mL multiple dose vials
How Dispensed:OTC
Amount of Active Ingredients:Each mL contains 100 mg of iron as iron dextran complex
Route of Administration:IM Injection
Species:Swine (baby pigs)
Labeled Dosage: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.
Pioneer Product:Iron Dextran Complex Injection, Boehringer Ingelheim Vetmedica (formerly, Fermenta Animal Health Co.
NADA 106-772

 

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

Tolerance
The tolerance established for the pioneer product applies to the generic product. A tolerance has not been established for iron dextran.

Withdrawal Time
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.

Attachments:

  1. generic product labeling
  2. pioneer product labeling

cc:

  1. Courtesy copy to the sponsor
  2. HFV-199, ANADA Orig. A0000 M0001[white copy]
  3. HFV-2 (Special Mailing List)
  4. HFV-12 (FOI Staff)
  5. HFV-102 (GADQC Reserve Copy)
  6. HFV-102 Green Book (NTurner)
  7. HFA-305 (Dockets Management Branch)
  8. HFR-SW350 (KAN-DO: District Office Copy)
  9. SHansard:HFV-102:827-0211:PANADA:6/04/98:rev.7/8/98.
  10. ec: CVM RecordsONADE\A200254A0000foi.sum