Cythioate: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Cythioate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: dogs.
Products
- Proban® Tablets (NADA/ANADA 132-337)
Proban® Tablets NADA 132-337, Supplemental approval, April 25, 1994; sponsor Elanco US Inc.; species: dogs; foi_id 1634; FDA PDF
Indication
Control of fleas on infested dogs (indication unchanged by this supplement).
Dose regimen
30 mg cythioate per 20 pounds of body weight, Oral, every third day or twice a week
30 mg cythioate per 20 pounds of body weight every third day or twice a week
Target-animal safety
dose multiples 3X; duration one year.
An addition to the "Precautions" section relating to a controlled safety study where no adverse reactions were observed in dogs which received three times the labeled dosage for a one year duration.
| Finding | Quote |
|---|---|
| No adverse reactions observed in dogs receiving three times the labeled dosage for one year (controlled safety study referenced for a labeling addition) | no adverse reactions were observed in dogs which received three times the labeled dosage for a one year duration |
Extraction notes: Supplemental approval adding a 90 mg tablet (existing 30 mg tablet). 'The approval of the 90 mg tablet did not require safety and effectiveness data, as the dosage remains the same.' The target_animal_safety entry only reflects a one-sentence labeling reference to a prior 3X/one-year safety study; no study details are given.
Reproduce: foi_structured_search(query="Cythioate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).