Selamectin: what the FDA reviewed for dog products
8 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Selamectin, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Cats; Dogs; Dogs and cats.
Products
- Revolt® (NADA/ANADA 200-673)
- Revolution® (NADA/ANADA 141-152)
- SENERGY™ (NADA/ANADA 200-670)
- SelaSpot™ (NADA/ANADA 200-696)
- Selamectin (NADA/ANADA 200-769)
- Selarid® (NADA/ANADA 200-663)
Revolt® NADA 200-673, Original approval, April 22, 2020; sponsor Aurora Pharmaceutical, Inc.; species: Dogs and cats; foi_id 8867; FDA PDF
Indication
Dogs 6 weeks and older: kills adult fleas and prevents flea eggs hatching for one month; prevention and control of flea infestations (C. felis); prevention of heartworm disease (D. immitis); treatment and control of ear mites (O. cynotis); treatment and control of sarcoptic mange (S. scabiei); control of tick infestations (D. variabilis). Cats 8 weeks and older: fleas, heartworm prevention, ear mites, roundworm (T. cati) and hookworm (A. tubaeforme).
Dose regimen
2.7 mg/lb (6 mg/kg) minimum, topical, monthly (per RLNAD Revolution label; one month of flea effect per dose), Entire contents of a single-dose applicator/tube by weight band (60 mg/mL and 120 mg/mL strengths); dogs 6 weeks and older, cats 8 weeks and older
The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight.
Effectiveness
Bioequivalence (ANADA): biowaiver granted on formulation characteristics; no in vivo bioequivalence, effectiveness or target animal safety study; result: Biowaiver; generic topical solution has the same active ingredient, concentration and dosage form as the RLNAD Revolution (NADA 141-152, Zoetis) with no inactive ingredients that may significantly affect bioavailability
Based on the formulation characteristics of the generic product, Aurora Pharmaceutical, Inc., was granted a biowaiver for the generic product Revolt™ (selamectin) topical solution.
Extraction notes: Generic ANADA approved by biowaiver; the summary contains only General Information, a bioequivalence waiver statement, human food safety (not required), user safety label text and agency conclusions. No PK, target animal safety, effectiveness studies or adverse reaction data. Sponsor Aurora Pharmaceutical, Inc.; approved April 22, 2020.
Revolution® NADA 141-152, Supplemental approval, August 05, 1999; sponsor Zoetis Inc.; species: Dogs; foi_id 670; FDA PDF
Indication
Supplemental indication: control of tick (Dermacentor variabilis) infestations in dogs.
Dose regimen
2.7 mg/lb (6 mg/kg) minimum, topical, monthly, Tick studies dosed monthly for 3 months; a second dose 14 days after the first provided more rapid tick control
The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight. Administer the entire contents of a single dose tube of Revolution topically in accordance with the following tables.
Effectiveness
Placebo-controlled laboratory dose-confirmation study 1061E-60-98-242 (Nu-Era Farms, Oklahoma): 24 dogs, 8 per group; T1 placebo every 2 weeks x6, T2 selamectin >=6 mg/kg every 2 weeks x6, T3 selamectin >=6 mg/kg monthly x3; 50 adult D. variabilis infestations on 12 occasions over 90 days; viable attached ticks counted on day 5 post-infestation; n = 24; primary endpoint: Percent reduction in mean tick counts on the fifth day after each infestation vs placebo; result: Monthly dosing: 55.9%-88.8% in the first month, then 97.8%-99.6% after the second dose (days 32-85); every-2-week dosing: 79.3%-80.8% in the first 9 days then 97.4%-100%. Two further studies (1061C-60-98-255, 1061C-60-98-256) confirmed control; in 1061C-60-98-256 monthly dosing controlled ticks for two weeks after each treatment.
Animals: 24 dogs (12 males and 12 females), 4 months to 8 years of age, 8 per treatment group.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| None observed (all three tick studies) | Adverse Drug Reactions: None observed |
Extraction notes: Supplement for the tick claim in dogs only (species_class recorded as Dogs although the label covers dogs and cats). No new safety studies ('Target animal safety studies in support of this supplement are referenced in the FOI Summary for the original NADA 141-152 approval'). No PK content. Study conclusion: 'Monthly administration of selamectin providing a minimum topical dose of 6 mg/kg was effective in controlling Dermacentor variabilis ticks on dogs after a second dose was applied. A second dose at 14 days provided control more rapidly.'
SelaSpot™ NADA 200-696, Original approval, December 16, 2020; sponsor Bimeda Animal Health Ltd.; species: Dogs and cats; foi_id 10188; FDA PDF
Indication
Dogs 6 weeks and older: kills adult fleas and prevents flea eggs hatching for one month; prevention and control of flea infestations (C. felis); prevention of heartworm disease (D. immitis); treatment and control of ear mites (O. cynotis); treatment and control of sarcoptic mange (S. scabiei); control of tick infestations (D. variabilis). Cats 8 weeks and older: fleas, heartworm prevention, ear mites, roundworm (T. cati) and hookworm (A. tubaeforme).
Dose regimen
2.7 mg/lb (6 mg/kg) minimum, topical, monthly (per RLNAD Revolution label; one month of flea effect per dose), Entire contents of a single-dose applicator/tube by weight band (60 mg/mL and 120 mg/mL strengths); dogs 6 weeks and older, cats 8 weeks and older
The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight.
Effectiveness
Bioequivalence (ANADA): biowaiver granted on formulation characteristics; no in vivo bioequivalence, effectiveness or target animal safety study; result: Biowaiver; generic topical solution has the same active ingredient, concentration and dosage form as the RLNAD Revolution (NADA 141-152, Zoetis) with no inactive ingredients that may significantly affect bioavailability
Based on the formulation characteristics of the generic product, Bimeda Animal Health Ltd., was granted a biowaiver for the generic product SelaSpot™ (selamectin) topical solution.
Extraction notes: Generic ANADA approved by biowaiver; the summary contains only General Information, a bioequivalence waiver statement, human food safety (not required), user safety label text and agency conclusions. No PK, target animal safety, effectiveness studies or adverse reaction data. Sponsor Bimeda Animal Health Ltd.; approved December 16, 2020.
Selamectin NADA 200-769, Original approval, January 30, 2024; sponsor ZyVet Animal Health, Inc.; species: Dogs and cats; foi_id 14985; FDA PDF
Indication
Dogs 6 weeks and older: kills adult fleas and prevents flea eggs hatching for one month; prevention and control of flea infestations (C. felis); prevention of heartworm disease (D. immitis); treatment and control of ear mites (O. cynotis); treatment and control of sarcoptic mange (S. scabiei); control of tick infestations (D. variabilis). Cats 8 weeks and older: fleas, heartworm prevention, ear mites, roundworm (T. cati) and hookworm (A. tubaeforme).
Dose regimen
2.7 mg/lb (6 mg/kg) minimum, topical, monthly (per RLNAD Revolution label; one month of flea effect per dose), Entire contents of a single-dose applicator/tube by weight band (60 mg/mL and 120 mg/mL strengths); dogs 6 weeks and older, cats 8 weeks and older
The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight.
Effectiveness
Bioequivalence (ANADA): biowaiver granted on formulation characteristics; no in vivo bioequivalence, effectiveness or target animal safety study; result: Biowaiver; generic topical solution has the same active ingredient, concentration and dosage form as the RLNAD Revolution (NADA 141-152, Zoetis) with no inactive ingredients that may significantly affect bioavailability
Based on the formulation characteristics of the generic product, ZyVet Animal Health, Inc., was granted a biowaiver for the generic product Selamectin topical solution.
Extraction notes: Generic ANADA approved by biowaiver; the summary contains only General Information, a bioequivalence waiver statement, human food safety (not required), user safety label text and agency conclusions. No PK, target animal safety, effectiveness studies or adverse reaction data. Sponsor ZyVet Animal Health, Inc.; approved January 30, 2024.
Revolution® NADA 141-152, Supplemental approval, June 13, 2000; sponsor Zoetis Inc.; species: Cats; foi_id 671; FDA PDF
Indication
Supplemental indication: control of intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections in cats (treatment claim previously approved).
Dose regimen
2.7 mg/lb (6 mg/kg) minimum, topical, monthly, Field study dosed monthly for 2 months (days 0 and 30)
The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight. Administer the entire contents of a single dose tube of Revolution topically in accordance with the following tables.
Effectiveness
Multi-site (5 clinics) field study in client-owned cats with natural hookworm and/or roundworm infections: selamectin >=6 mg/kg topical monthly x2 vs pyrantel pamoate 20 mg/kg + praziquantel 5 mg/kg oral (Drontal); 83 cats enrolled, 70 evaluable; fecal egg counts on days 0, 30 and 60; n = 70 evaluable cats; primary endpoint: Percent reduction in geometric mean fecal egg counts vs day 0; result: Selamectin: roundworm eggs reduced 99.5% (day 30) and 100% (day 60); hookworm eggs reduced 98.8% and 100%; Drontal 99.4%/100% and 98.0%/99.5%; treatment groups differed by fewer than 2 eggs per gram from day 30 onward
Of these, 70 were considered evaluable for safety and effectiveness.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Drowsiness/lethargy after administration (two selamectin-treated cats) | Adverse Drug Reactions: Two cats treated with selamectin were observed to be drowsy or lethargic following administration of the drug. |
Extraction notes: This supplement to a dog/cat application concerns cats only; species recorded as Cats and the n_dogs field holds the cat count. Of the 70 evaluable cats, 51 received selamectin and 19 the control (written 'Fifty-one' in the text). No new target animal safety studies (referenced to the original approval); no PK content.
SENERGY™ NADA 200-670, Original approval, March 10, 2020; sponsor Virbac AH, Inc.; species: Dogs and cats; foi_id 8527; FDA PDF
Indication
Dogs 6 weeks and older: kills adult fleas and prevents flea eggs hatching for one month; prevention and control of flea infestations (C. felis); prevention of heartworm disease (D. immitis); treatment and control of ear mites (O. cynotis); treatment and control of sarcoptic mange (S. scabiei); control of tick infestations (D. variabilis). Cats 8 weeks and older: fleas, heartworm prevention, ear mites, roundworm (T. cati) and hookworm (A. tubaeforme).
Dose regimen
2.7 mg/lb (6 mg/kg) minimum, topical, monthly (per RLNAD Revolution label; one month of flea effect per dose), Entire contents of a single-dose applicator/tube by weight band (60 mg/mL and 120 mg/mL strengths); dogs 6 weeks and older, cats 8 weeks and older
The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight.
Effectiveness
Bioequivalence (ANADA): biowaiver granted on formulation characteristics; no in vivo bioequivalence, effectiveness or target animal safety study; result: Biowaiver; generic topical solution has the same active ingredient, concentration and dosage form as the RLNAD Revolution (NADA 141-152, Zoetis) with no inactive ingredients that may significantly affect bioavailability
Based on the formulation characteristics of the generic product, Chanelle Pharmaceuticals Manufacturing Ltd., was granted a biowaiver for the generic product SENERGY™ (selamectin) topical solution.
Extraction notes: Generic ANADA approved by biowaiver; the summary contains only General Information, a bioequivalence waiver statement, human food safety (not required), user safety label text and agency conclusions. No PK, target animal safety, effectiveness studies or adverse reaction data. Sponsor Chanelle Pharmaceuticals Manufacturing Ltd. (catalogue lists Virbac AH, Inc.); approved March 10, 2020.
Revolution® NADA 141-152, Original approval, May 26, 1999; sponsor Zoetis Inc.; species: Dogs and cats; foi_id 669; FDA PDF
Indication
Kills adult fleas and prevents flea eggs from hatching for one month; prevention and control of flea infestations (C. felis), prevention of heartworm disease (D. immitis), treatment and control of ear mites (O. cynotis) in dogs and cats; treatment and control of sarcoptic mange (S. scabiei) in dogs; treatment of hookworm (A. tubaeforme) and roundworm (T. cati) in cats; dogs and cats six weeks and older.
Dose regimen
2.7 mg/lb (6 mg/kg) minimum, topical, monthly (single-dose tube per weight band), Dogs and cats six weeks of age and older; tube strengths 15-240 mg; effectiveness studies used monthly dosing (up to 6 months in the heartworm field study)
The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight. Administer the entire contents of a single dose tube of Revolution topically in accordance with the following tables.
Target-animal safety
dose multiples 1X, 3X, 5X, 10X; duration Once every 28 days for 7 treatments (196 days), starting at 6 weeks of age; animals 40 beagle puppies (8 per group).
Animals: 40 beagle puppies (20 male, 20 female), 6 weeks of age, 8 dogs per treatment group. Dosage Groups: T1: Saline T2: Selamectin (≥6 mg/kg), 1x recommended dose T3: Selamectin (≥18 mg/kg), 3x recommended dose T4: Selamectin (≥30 mg/kg), 5x recommended dose T5: Selamectin (≥60 mg/kg), 10x recommended dose Route of Administration: Topical Frequency of Treatment: Once every 28 days for 7 treatments Duration of Study: 196 days
| Finding | Quote |
|---|---|
| No treatment-related effects; no clinically significant clinical pathology or histopathology changes at up to 10X | There were no treatment-related effects in any of the dogs in the study. |
| Application-site hair clumping, powdery residue and hair discoloration in all treated groups | Hair clumping, powdery residue, and hair discoloration were commonly observed at the treatment site in all groups receiving the test article. |
| Conclusion: 1X-10X monthly for seven treatments from 6 weeks of age was safe | Topical administration of selamectin once every 28 days at one, three, five, and ten times the recommended minimum dosage of 6 mg/kg for seven treatments starting at 6 weeks of age was safe in male and female puppies. |
| Avermectin-sensitive Collies: 1X, 3X, 5X topical every 28 days x3 was safe (sporadic salivation in all groups incl. placebo) | Topical administration of selamectin once every 28 days for three treatments at one, three, or five times the recommended minimum dosage of 6 mg/kg was safe in avermectin-sensitive Collie dogs. |
| Oral dosing in avermectin-sensitive Collies (non-market formulation, 4 dogs, escalating 2.5-15 mg/kg): mild ataxia in one dog after 5 mg/kg | However, mild ataxia was noted in one dog following oral treatment with 5 mg/kg (0.4 - 0.7X the minimum recommended topical dose). |
| Heartworm-positive dogs: 3X every 28 days x3 safe; no treatment-related adverse reactions | Topical administration of selamectin once every 28 days for three treatments at three times the recommended minimum dosage of 6 mg/kg was safe in dogs infected with viable adult D. immitis. |
Effectiveness
Multi-site field study in client-owned dogs with natural flea infestations (8 clinics, US and Canada): selamectin >=6 mg/kg topical monthly for 3 months (311 dogs treated; 220 primary cases analysed) vs fenthion 4-8 mg/kg positive control (115 treated; 81 analysed); flea comb counts on days 0, 14, 30, 60, 90; FAD signs assessed; n = 220; primary endpoint: Percent reduction in geometric mean flea comb counts vs day 0; result: Selamectin 89.4%, 92.0%, 99.0% and 99.8% reduction on days 14, 30, 60 and 90 (fenthion 72.8%-86.1%); 92% effective within 30 days of first dose and >=99% after second and third doses; improvement in FAD signs
Selamectin 27.0 2.9 2.2 0.3 0.1 % Reduction N/A 89.4 92.0 99.0 99.8 # Dogs 220 214 212 203 198
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting (heartworm prevention field study, 298 selamectin-treated dogs, monthly x6) | 3 dogs | Other clinical observations seen in dogs treated with selamectin include: vomiting (in 3 dogs), diarrhea/loose stools (in 3 dogs), treatment site residue (in 1 dog), and salivation (in 1 dog). | |
| Diarrhea/loose stools (heartworm prevention field study) | 3 dogs | Other clinical observations seen in dogs treated with selamectin include: vomiting (in 3 dogs), diarrhea/loose stools (in 3 dogs), treatment site residue (in 1 dog), and salivation (in 1 dog). | |
| Treatment site residue (heartworm prevention field study) | 1 dog | Other clinical observations seen in dogs treated with selamectin include: vomiting (in 3 dogs), diarrhea/loose stools (in 3 dogs), treatment site residue (in 1 dog), and salivation (in 1 dog). | |
| Salivation (heartworm prevention field study) | 1 dog | Other clinical observations seen in dogs treated with selamectin include: vomiting (in 3 dogs), diarrhea/loose stools (in 3 dogs), treatment site residue (in 1 dog), and salivation (in 1 dog). | |
| Vomiting with brief anorexia after first dose (flea field study, one dog) | A dog vomited after the first treatment with selamectin followed by a brief period (≤ 24 hours) of anorexia. | ||
| Diarrhea, anorexia, treatment-site residue, alopecia near treatment site (flea field study, one dog each) | Other clinical observations seen in one dog each included diarrhea, anorexia, residue at the treatment site and alopecia near the treatment site. |
Extraction notes: Combined dog-and-cat original approval (43-page summary) with no PK section. Effectiveness record is the dog flea field study; 'Two hundred and twenty' primary dogs is written in words in the Animals paragraph, so n_dogs is quoted from the results table row (column order: day 0/14/30/60/90 geometric mean counts, then % reduction, then # dogs). Other dog field studies: heartworm prevention (298 dogs, monthly x6, 100% antigen/microfilaria negative at days 180 and 300), ear mites (90 dogs, 2 doses, 90.4% mite-free at day 60 vs 65.0% for Otomite), sarcoptic mange (75 dogs, 100% mite-free at day 60). Dog lab studies: flea dose determination selected 6 mg/kg (94.5% at day 30); heartworm 100% prevention with 3 or 6 mg/kg; ear mites 100%; sarcoptic mange >93%. Adverse-reaction counts have no formal denominator in the quote; the heartworm field study treated 298 dogs. Two deaths of debilitated mange-infested dogs (one euthanized in lab study 1062C-60-95-172, one died day 4 in the field study) were attributed to pre-existing disease. TAS: six dog studies (margin of safety 40 puppies 1X-10X; oral 12 dogs; heartworm-positive 20 dogs 3X; Collies 24 dogs 1X-5X; oral Collies 4 dogs; male reproduction 20 dogs 3X q14d x17; female reproduction 44 dogs 3X) plus five cat studies (kittens 1X-10X x7, oral cats caused salivation/vomiting, heartworm-positive cats 4X, male and female reproduction 3X).
Selarid® NADA 200-663, Original approval, November 20, 2019; sponsor Norbrook Laboratories, Ltd.; species: Dogs and cats; foi_id 7948; FDA PDF
Indication
Dogs 6 weeks and older: kills adult fleas and prevents flea eggs hatching for one month; prevention and control of flea infestations (C. felis); prevention of heartworm disease (D. immitis); treatment and control of ear mites (O. cynotis); treatment and control of sarcoptic mange (S. scabiei); control of tick infestations (D. variabilis). Cats 8 weeks and older: fleas, heartworm prevention, ear mites, roundworm (T. cati) and hookworm (A. tubaeforme).
Dose regimen
2.7 mg/lb (6 mg/kg) minimum, topical, monthly (per RLNAD Revolution label; one month of flea effect per dose), Entire contents of a single-dose applicator/tube by weight band (60 mg/mL and 120 mg/mL strengths); dogs 6 weeks and older, cats 8 weeks and older
The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight.
Effectiveness
Bioequivalence (ANADA): biowaiver granted on formulation characteristics; no in vivo bioequivalence, effectiveness or target animal safety study; result: Biowaiver; generic topical solution has the same active ingredient, concentration and dosage form as the RLNAD Revolution (NADA 141-152, Zoetis) with no inactive ingredients that may significantly affect bioavailability
Based on the formulation characteristics of the generic product, Norbrook Laboratories, Ltd., was granted a biowaiver for the generic product Selarid™ (selamectin) topical solution.
Extraction notes: Generic ANADA approved by biowaiver; the summary contains only General Information, a bioequivalence waiver statement, human food safety (not required), user safety label text and agency conclusions. No PK, target animal safety, effectiveness studies or adverse reaction data. Sponsor Norbrook Laboratories, Ltd.; approved November 20, 2019.
Reproduce: foi_structured_search(query="Selamectin") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).