Melarsomine dihydrochloride: what the FDA reviewed for dog products

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

Products

DIROBAN® NADA 200-609, Original approval, February 17, 2017; sponsor Anzac Animal Health, LLC; species: Dogs; foi_id 201; FDA PDF

Indication

Treatment of stabilized Class 1, 2 and 3 heartworm disease caused by immature (4 month-old, stage L5) to mature adult Dirofilaria immitis infections.

Dose regimen

2.5 mg/kg per injection, deep intramuscular injection in the epaxial (lumbar, L3-L5) muscles only, twice, 24 hours apart (Class 1 and 2), Class 1 and 2: 2.5 mg/kg twice 24 hours apart; optional second series four months later. Class 3: single injection of 2.5 mg/kg, then about 1 month later 2.5 mg/kg twice 24 hours apart. 2.5 mg/kg = 1.1 mg/lb = 0.1 mL/kg of reconstituted 25 mg/mL solution; limited data for >5.0 mL at one injection site.

DIROBAN should be administered intramuscularly in the lumbar (L3 - L5) muscles at a dose of 2.5 mg/kg twice, 24 hours apart.

Extraction notes: Generic (ANADA) of IMMITICIDE (NADA 141-042). Waiver from demonstrating bioequivalence granted on formulation characteristics (sterile powder, 50 mg/vial reconstituted in 2 mL). No effectiveness, target animal safety or PK studies in the summary ('CVM did not require effectiveness studies for this approval'; 'CVM did not require target animal safety studies for this approval').

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