Imidacloprid: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Imidacloprid, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- advantus™ (NADA/ANADA 141-435)
advantus™ NADA 141-435, Original approval, January 09, 2015; sponsor Elanco US Inc.; species: Dogs; foi_id 927; FDA PDF
Indication
Kills adult fleas; treatment of flea infestations on dogs and puppies 10 weeks of age and older weighing 4 pounds or greater.
Dose regimen
0.34 mg/lb (0.75 mg/kg) minimum, Oral (soft chewable tablet), Once daily as needed; not more than one tablet a day, One 7.5 mg soft chew for 4-22 lb; one 37.5 mg soft chew for 23-110 lb; not for puppies under 10 weeks or dogs under 4 lb; OTC
The dose of imidacloprid is 0.34 mg/lb (0.75 mg/kg) administered orally.
Target-animal safety
dose multiples 0X, 0.9X (1.7 mg/lb/day), 2.7X (5.1 mg/lb/day), 4.5X (8.5 mg/lb/day); duration Once daily orally for 182 days (6 months) starting at 10 weeks of age; multiples of the maximum exposure dose of 1.9 mg/lb/day; animals Thirty-two (16 males, 16 females).
Thirty-two Beagles (16 males and 16 females) approximately ten weeks of age at the time of first administration were used in the study.
| Finding | Quote |
|---|---|
| No clinically relevant drug-related effects on any parameter | There were no clinically-relevant, drug-related effects on physical examination, body weight, food consumption, clinical pathology, necropsy, or histopathology results. |
| Well tolerated for 6 months at up to 4.5X the maximum exposure dose in puppies from 10 weeks of age | Imidacloprid, administered orally once daily at 1.7, 5.1, or 8.5 mg/lb/day (0.9X, 2.7X and 4.5X, respectively, of the maximum exposure dose of 1.9 mg/lb/day) for 6 months, was well tolerated and did not produce clinically- relevant findings in Beagles, when dosing started at 10 weeks of age. |
Effectiveness
Randomized, vehicle-controlled multi-site field study (Study PAH-09-0040; 16 US sites) of imidacloprid chewable tablets given once daily for 14 days (0.3-1.9 mg/lb); 331 dogs in safety population (206 treated, 125 control), 173 primary dogs in the effectiveness analysis; n = 104 treated, 69 control (effectiveness analysis); primary endpoint: Percent reduction in geometric mean live flea counts on Day 14 vs control (success = 90% or greater); result: Geometric mean live flea counts 0.4 (treated) vs 21.0 (control); effectiveness 98.2% (p<0.0001)
The effectiveness analysis included 104 dogs in the treated group and 69 dogs in the control group. The geometric means of the live flea counts were 0.4 and 21.0 for the treated and control groups, respectively. The effectiveness was 98.2%.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 8 (3.8%) | 4 (3.2%) | Vomiting 8 (3.8%) 4 (3.2%) |
| Inappetence | 6 (2.9%) | 3 (2.4%) | Inappetence 6 (2.9%) 3 (2.4%) |
| Lethargy | 4 (1.9%) | 4 (3.2%) | Lethargy 4 (1.9%) 4 (3.2%) |
| Diarrhea, flatulence | 3 (1.5%) | 4 (3.2%) | Diarrhea, flatulence 3 (1.5%) 4 (3.2%) |
| Ataxia | 1 (0.5%) | None | Ataxia 1 (0.5%) None |
Extraction notes: No PK data in the summary. Safety study n_animals is spelled 'Thirty-two' in the design quote. Adverse reactions from Table 4 of the field study (imidacloprid N=206 vs control N=125), quoted as flattened rows. Laboratory dose confirmation (48 dogs): 98.6/99.9/100% at 8/12/24 h; speed-of-kill study: 96.6% at 4 h and 99.9% at 24 h. Sponsor at approval was Piedmont Animal Health (catalogue lists Elanco).
Reproduce: foi_structured_search(query="Imidacloprid") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).