Nitenpyram: what the FDA reviewed for dog products
3 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Nitenpyram, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs and Cats; Dogs and cats.
Products
- CAPSTAR® (NADA/ANADA 141-175)
- Nitenpyram Tablets (NADA/ANADA 200-858)
Nitenpyram Tablets NADA 200-858, Original approval, June 08, 2026; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs and cats; foi_id 18554; FDA PDF
Indication
Kill adult fleas; treatment of flea infestations on dogs, puppies, cats and kittens 2 pounds of body weight or greater and 4 weeks of age and older
Dose regimen
one 11.4 mg tablet (dog or cat 2-25 lbs) or one 57.0 mg tablet (dog 25.1-125 lbs), Oral, one tablet per administration (dosing frequency not stated in summary), Weigh pet prior to administration; do not administer to pets under 2 pounds
Nitenpyram Tablets should be administered according to the following schedule. Weigh your pet prior to administration to ensure proper dosage. Do not administer to pets under 2 pounds. Recommended Dosage Schedule Species Body Weight Dose Nitenpyram Per Tablet Dog or Cat 2-25 lbs. One tablet 11.4 mg Dog 25.1-125 lbs. One tablet 57.0 mg
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 5116.00 (ng/mL)*hour (geometric mean) | generic 11.4 mg tablet, single oral dose, 28 fasted dogs, crossover; row order: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | AUC (ng/mL)*hour 5116.00† 5166.00† 0.99 0.95 1.03 |
| auc | 5166.00 (ng/mL)*hour (geometric mean) | RLNAD CAPSTAR 11.4 mg tablet, single oral dose, 28 fasted dogs; same flattened table row | AUC (ng/mL)*hour 5116.00† 5166.00† 0.99 0.95 1.03 |
| cmax | 1466.74 ng/mL (geometric mean) | generic 11.4 mg tablet, single oral dose, 28 fasted dogs; row order: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | CMAX (ng/mL) 1466.74† 1499.71† 0.98 0.94 1.02 |
| cmax | 1499.71 ng/mL (geometric mean) | RLNAD CAPSTAR 11.4 mg tablet, single oral dose, 28 fasted dogs; same flattened table row | CMAX (ng/mL) 1466.74† 1499.71† 0.98 0.94 1.02 |
| tmax | 0.77 hours (SD 0.35), arithmetic mean | generic 11.4 mg tablet, single oral dose, 28 fasted dogs; row order: generic mean (SD), RLNAD mean (SD), ratio/CI not estimated | TMAX (hours) (SD)‡ 0.77 (0.35)‡ 0.73 (0.43)‡ NE NE NE |
| tmax | 0.73 hours (SD 0.43), arithmetic mean | RLNAD CAPSTAR 11.4 mg tablet, single oral dose, 28 fasted dogs; same flattened table row | TMAX (hours) (SD)‡ 0.77 (0.35)‡ 0.73 (0.43)‡ NE NE NE |
| other | AUC geometric mean ratio 0.99 (90% CI 0.95-1.03) | generic:RLNAD, dogs; acceptance limits 0.80-1.25 | Parameter Generic Mean RLNAD Mean Ratio◊ Lower 90% CI Upper 90% CI AUC (ng/mL)*hour 5116.00† 5166.00† 0.99 0.95 1.03 |
| other | CMAX geometric mean ratio 0.98 (90% CI 0.94-1.02) | generic:RLNAD, dogs; acceptance limits 0.80-1.25 | Parameter Generic Mean RLNAD Mean Ratio◊ Lower 90% CI Upper 90% CI AUC (ng/mL)*hour 5116.00† 5166.00† 0.99 0.95 1.03 CMAX (ng/mL) 1466.74† 1499.71† 0.98 0.94 1.02 |
Effectiveness
Bioequivalence study (not a clinical effectiveness study): pivotal GLP in vivo blood-level study, randomized, masked, two-period, two-sequence, single-dose crossover in fasted dogs, generic 11.4 mg vs RLNAD CAPSTAR 11.4 mg tablet, 14-day washout; n = 28; primary endpoint: CMAX and AUC (time 0 to last quantifiable concentration); 90% CI of geometric mean ratio within 0.80-1.25; result: Bioequivalent: AUC ratio 0.99 (90% CI 0.95-1.03), CMAX ratio 0.98 (90% CI 0.94-1.02)
The dog in vivo blood-level study was conducted in 28 healthy, fasted dogs. The pivotal parameters to evaluate bioequivalence are the observed maximum plasma drug concentration (CMAX) and area under the concentration-time curve (AUC) from time 0 to the last sampling time before the first unquantifiable concentration after CMAX. Bioequivalence was demonstrated between the 11.4 mg RLNAD nitenpyram tablets and the 11.4 mg generic nitenpyram tablets by the average bioequivalence approach as described in the Statistical Methods section below.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (dog bioequivalence study): none related to test or reference article | There were no serious adverse events related to the test or reference article reported during the study. |
Extraction notes: Generic (ANADA); no target animal safety or clinical effectiveness studies required. PK values are from flattened Table II.2 (dog BE study, Study No. 024-01986, 28 intact male and female dogs 2-9 years). A parallel cat BE study (28 cats; AUC 49455 vs 48031, CMAX 4085 vs 3741) is in the summary but not extracted. Biowaiver granted for the 57.0 mg tablet (dogs) on dissolution data: f2 = 55 for 11.4 mg generic vs RLNAD; >85% dissolved in 15 minutes for 57.0 mg. Adverse-reaction row has no counts (summary reports only that no serious events occurred).
CAPSTAR® NADA 141-175, Supplemental approval, June 11, 2003; sponsor Sergeant’s Pet Care Products LLC; species: Dogs and Cats; foi_id 685; FDA PDF
Indication
Kill adult fleas; treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and older and 2 pounds of body weight or greater
Dose regimen
one tablet per Recommended Dosage Schedule (by body weight), Oral, single dose; another dose may be given as often as once per day if reinfested, Do not administer to pets under 2 pounds
Weigh your pet prior to administration to ensure proper dosage. Do not administer to pets under 2 pounds. A single dose of CAPSTAR® should kill the adult fleas on your pet. If your pet gets reinfested with fleas, you can safely give another dose as often as once per day.
Effectiveness
No new studies: Category II supplemental labeling change (adds 'kill adult fleas' and references to concurrent use with PROGRAM/SENTINEL Flavor Tabs supported under NADAs 141-205 and 141-204); result: Labeling revised; no reevaluation of parent-application safety/effectiveness data required
According to the Center's supplemental approval policy (21 CFR 514.106), this is a Category II change. The approval of this change is not expected to have any adverse effect on the safety or effectiveness of this new animal drug.
Extraction notes: Supplemental approval; effectiveness and safety sections refer to the original approval FOI summary (October 20, 2000) and to NADAs 141-204/141-205 for concurrent use. Dosage schedule: one 11.4 mg tablet for dogs or cats 2-25 lbs, one 57 mg tablet for dogs 25.1-125 lbs. No PK, TAS or adverse-reaction data.
CAPSTAR® NADA 141-175, Original approval, October 20, 2000; sponsor Sergeant’s Pet Care Products LLC; species: Dogs and cats; foi_id 684; FDA PDF
Indication
Treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater
Dose regimen
minimum 1.0 mg/kg (0.45 mg/lb) body weight, Oral, as needed, as often as once per day, Do not administer to pets under 2 pounds; one 11.4 mg tablet for dogs or cats 2-25 lbs, one 57 mg tablet for dogs 25.1-125 lbs (schedule)
CAPSTAR Tablets should be administered orally, at a minimum dosage rate of 1.0 mg/kg (0.45 mg/lb) body weight, according to the Recommended Dosage Schedule below. Weigh your pet prior to administration to ensure proper dosage. Do not administer to pets under 2 pounds. CAPSTAR may be used as needed, as often as once per day, whenever you see fleas on your pet.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 17422 ng·hr/mL (%CV 11%) | AUC(0-LOQ), swallow tablet (market formulation), single oral 57 mg dose ~1.0 mg/kg, 12 beagle dogs, two-period crossover; row order: swallow mean (%CV), flavor mean (%CV), 90% CI | 17422 (11%) 16937 (20%) 95-111% |
| auc | 16937 ng·hr/mL (%CV 20%) | AUC(0-LOQ), flavor tablet (reference formulation used in pivotal studies), single oral dose ~1.0 mg/kg, 12 beagle dogs; same flattened table row | 17422 (11%) 16937 (20%) 95-111% |
| cmax | 4787 ng/mL (%CV 16%) | swallow tablet (market formulation), single oral dose ~1.0 mg/kg, 12 beagle dogs; row order: swallow mean (%CV), flavor mean (%CV), 90% CI | Cmax (ng/mL) 4787 (16%) 4216 (22%) 98-129% |
| cmax | 4216 ng/mL (%CV 22%) | flavor tablet (reference), single oral dose ~1.0 mg/kg, 12 beagle dogs; same flattened table row | Cmax (ng/mL) 4787 (16%) 4216 (22%) 98-129% |
| other | 90% CI 95-111% (AUC ratio test/reference) | swallow vs flavor tablet bioequivalence, dogs; AUC met bioequivalence criterion | 90% confidence limits** AUC(0-LOQ) (ng•hr•mL-1) 17422 (11%) 16937 (20%) 95-111% |
| other | 90% CI = 98-129 (Cmax ratio test/reference) | swallow vs flavor tablet, dogs; Cmax did not meet bioequivalence criterion but swallow tablet accepted | Though the test product (swallow tablet) meets the criteria for bioequivalence (the 90% confidence interval lies within ± 20% of the mean of the reference product) in terms of the AUC(0-LOQ) parameter, it does not in terms of the Cmax parameter (90% CI = 98-129). |
Target-animal safety
dose multiples 1X, 3X, 5X; duration daily for six months; animals 24 male and 24 female.
Animals: Forty-eight beagle dogs (24 male and 24 female), 8 weeks old 2 4 Freedom of Information Summary Study Design: The dogs were divided into four groups of six male and six female dogs per group.
| Finding | Quote |
|---|---|
| 6-month study (1X/3X/5X daily, 8-week-old beagles): no test article-related changes in any monitored variable | No test article-related changes were reported in the clinical observations, body weights, feed intake, physical and ophthalmoscopic examination, clinical pathology laboratory studies, organ weights, and macroscopic and microscopic pathological examinations. |
| Single 10X dose, with or without lufenuron, no adverse effects in 7-month-old dogs | Administration of nitenpyram tablets once at 10X the recommended dose, with and without lufenuron, did not produce any adverse effects in 7 month old dogs. |
| 1X and 3X daily for 6 weeks from 4 weeks of age: no adverse effects in puppies | Administration of nitenpyram at 1X and 3X the recommended dose daily for 6 weeks did not produce any adverse effects in 4 week old puppies. |
| 9-month reproduction study at 1X and 3X: no parental or neonatal toxicity; cleft palate in 1 (1X) and 2 (3X) puppies attributed to colony bloodlines | Cleft palate was reported in one puppy from the 1X group and 2 puppies from the 3X group. Based on the bloodlines of the puppies and the incidence of cleft palate in the breeding colony, these malformations were not considered to be treatment related. |
| 5X daily for 14 days concurrently with commercial ectoparasiticides: no adverse effects in puppies | Concomitant dosing with nitenpyram (5X the recommended dose) and one of several commercial ectoparasiticides (1X labeled dose) did not produce adverse effects in puppies. |
Effectiveness
Multi-centered, double-blinded, placebo-controlled clinical field study in client-owned dogs (11 sites); nitenpyram orally once a day per recommended schedule (minimum 1.0 mg/kg) for up to 16 daily treatments; investigator-administered dose at two visits 7-14 days apart with dead/moribund/live fleas counted 4-6 hours later; n = 160 (108 nitenpyram, 52 placebo at visit 1); primary endpoint: Percentage of dead and moribund fleas 4-6 hours after treatment; result: Visit 1: 98.6% dead/moribund fleas with nitenpyram vs 6.2% placebo; visit 2: 99.1% vs 13.1%
Nitenpyram 108 79 Placebo 52 45 Total 160 124 Table VI.5 - Study population by treatment group and age Nitenpyram Placebo 1-12 months 26 8 >1-5 years 34 25 >5-10 years 35 15 >10 years 13 4 2 0 Freedom of Information Summary Table VI.6 - Study population by treatment group and weight Nitenpyram Placebo 2-10 pounds 9 6 >10-25 pounds 30 8 >25-80 pounds 65 33 >80-125 pounds 4 5 Dosage: Nitenpyram was administered orally once a day according to the recommended dosage schedule (minimum dose of 1.0 mg/kg) for a maximum of 16 daily treatments. Controls: Placebo Parameters Evaluated: Effectiveness was evaluated during two visits 7 to 14 days apart. The tablet was administered by the investigator at each of these visits. Dead, moribund, and live fleas were counted 4-6 hours after treatment. Results: Effectiveness: Within 6 hours of initial administration, the nitenpyram group showed an average 98.6% dead and moribund fleas, while the placebo group had 6.2% dead and moribund fleas. At the second visit the nitenpyram group had an average 99.1% dead and moribund fleas within 6 hours of administration compared to 13.1% for the placebo group.
Extraction notes: Summary covers both cats and dogs; this record extracts the dog studies (cat dose titration, cat field study with 157 cats, cat BE study and cat safety studies are not extracted). Field study safety: 'There were a variety of adverse events reported during the trial. There was no evidence that any of the reported adverse events were drug-related.' with no incidence table, so adverse_reactions is empty. The effectiveness quote and TAS design_quote are verbatim spans that cross flattened tables and page breaks ('2 0 Freedom of Information Summary', '2 4 Freedom of Information Summary' are page-number artifacts). PK values come from the flattened Table VI.8 (swallow vs flavor tablet BE in 12 beagles, ~1.0 mg/kg); the swallow (market) tablet met BE on AUC but not Cmax (90% CI 98-129) and was accepted since higher bioavailability raised no safety concern. Dose characterization in dogs: 1.0 mg/kg gave 98.1% effectiveness at 7 h (>90% for at least 7 h); knockdown 99.1% by 8 h; 91% of 24-h flea kill by 4 h. Also a 10X single-dose tolerability study (18 beagles), 6-week puppy study (36 puppies), 9-month reproduction study (60 beagles) and a 14-day 5X ectoparasiticide interaction study (18 puppies).
Reproduce: foi_structured_search(query="Nitenpyram") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).