Amikacin Sulfate: what the FDA reviewed for dog products

1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Amikacin Sulfate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Canine.

Products

Amikacin Sulfate Injection NADA 200-178, Original approval, March 14, 1997; sponsor Cronus Pharma Specialities India Private Ltd.; species: Canine; foi_id 1417; FDA PDF

Indication

Genitourinary tract infections (cystitis) due to E. coli and Proteus sp.; skin and soft tissue infections due to Pseudomonas sp. and E. coli, in dogs

Dose regimen

Subcutaneous or Intramuscular Injection, 50 mg amikacin (base) per mL; dosage not stated in this summary

Route of Administration I. Subcutaneous or Intramuscular Injection

Effectiveness

Generic (ANADA) approval; bioequivalence to pioneer Amiglyde-V® Injection (NADA 127-892) established by chemical equivalence; in vivo bioequivalence study waived (labelled as bioequivalence waiver, not an effectiveness study); result: Waiver from in vivo bioequivalence testing granted April 13, 1994; same active ingredient, concentration, inactive ingredients and pH as pioneer

Based upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver April 13, 1994, from conducting an in vivo bioequivalence study with Amikacin Sulfate Injection.

Extraction notes: Generic ANADA (Phoenix Scientific, 1997). No dose regimen, PK, safety or field studies in this summary; dose_regimen.dose left null (only route and concentration are stated). Effectiveness field records the bioequivalence waiver.

Reproduce: foi_structured_search(query="Amikacin Sulfate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).