Glycopyrrolate: what the FDA reviewed for dog products

1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Glycopyrrolate, 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.

Products

Glycopyrrolate Injectable Robinul®-V NADA 200-365, Original approval, October 02, 2006; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs and cats; foi_id 1118; FDA PDF

Indication

Preanesthetic anticholinergic agent in dogs and cats.

Dose regimen

5 micrograms/lb body weight (0.25 mL per 10 lbs), Intravenous, intramuscular, or subcutaneous in dogs; intramuscular in cats, Single preanesthetic dose, Cats: same dose; administer 15 minutes prior to anesthetic for maximum anticholinergic effect

Recommended Dosage: Dogs: 5 micrograms/lb body weight (0.25 mL per 10 lbs body weight).

Effectiveness

ANADA (generic of ROBINUL-V, NADA 101-777): in vivo bioequivalence study waived based on formulation characteristics; no effectiveness study conducted; result: Waiver granted; injectable sterile solution with same active ingredient concentration and dosage form as the pioneer

Based on the formulation characteristics of the generic product Phoenix Scientific, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product Glycopyrrolate (glycopyrrolate) Injectable 0.2 mg/mL.

Extraction notes: Generic (ANADA) approval; no new studies. Catalogue lists the product as 'Glycopyrrolate Injectable / Robinul-V'; the summary's proprietary name is Glycopyrrolate Injectable 0.2 mg/mL (Robinul-V is the pioneer). Effectiveness field records the bioequivalence waiver only.

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