ANADA 200-177 Sulfadimethoxine - original approval

Approval Date: March 13, 1997

I. GENERAL INFORMATION

Dosage Form: Injection

How Supplied: 250 mL multiple dose vials

Amount of Active Ingredients: Each mL contains 400 mg of Sulfadimethoxine

Route of Administration: IV

Species: Bovine

Labeled Dosage: 25 mg/lb initial dose followed by 12.5 mg/lb for maintenance doses every 24 hours.

Indications for Use: For treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella Spp. Sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Pharmacological Category: Antibacterial

Pioneer Product: Albon® Injection - 40% manufactured by Hoffman-La Roche (NADA 41-245)

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 (53 FR 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). For certain dosage forms, the Agency grants a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; fifth GADPTRA Policy Letter). In lieu of in vivo bioequivalence testing, the bioequivalence of the generic product are based on the demonstrated chemical equivalence to the pioneer product.

Based on the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver June 9, 1994 (photocopy attached) from conducting an in vivo bioequivalence study with Sulfadimethoxine Injection 40%. The generic and pioneer products are solutions with the same active and inactive ingredients in the same concentration.

III. HUMAN FOOD SAFETY

Human Safety Relative to Food Consumption

• Tolerance
  The tolerances established for the pioneer product apply to the generic product.

  Tolerances are established for residues of sulfadimethoxine in uncooked edible tissues of cattle as follows: 0.1 part per million (negligible residue). In milk at 0.01 part per million (negligible residue) (21 CFR 556.640)

• Withdrawal Time
  When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal times are those previously assigned to the pioneer product. The withdrawal time for Sulfadimethoxine Injection 40% is established under 21 CFR 520.2220 (a)(2)(iii): 5 days for cattle: During treatment and for 60 hours (5 milkings) after the latest treatment for milk.
• Regulatory Method for Residues
  No new method required for this approval.

Human Safety Relative to Possession, Handling and Administration
Labeling contains adequate caution/warning statements.

IV. AGENCY CONCLUSIONS

This is an Abbreviated New Animal Drug Application (ANADA) filed under Section 512(b)(2) of the Federal, Food, Drug and Cosmetic (FFD&C) Act.

Bioequivalence for this generic animal drug, Sulfadimethoxine Injection 40%, was established by demonstration of chemical equivalence to the pioneer product, Hoffmann-La Roche's Albon® Injection 40% (NADA 041-245)

This generic product and the pioneer product have identical labeling indications for the 250 mL vial for use in cattle. The route and method of administration of the two drugs are identical. Both drugs are administered IV. The generic and pioneer products contain the same active and inactive ingredients in the same concentration.

Therefore, this ANADA satisfies the requirements of section 512 of the Act and demonstrates that Sulfadimethoxine Injection 40% is safe and effective for its labeled indications when used under its proposed conditions of use.

Attachments:

1. Generic Labeling:
   • Package insert
   • 250 mL container label
2. Pioneer Labeling:
   • Package insert
   • 250 mL container label

Copies of applicable labels may be obtained by writing to the:

Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855