Dexamethasone: what the FDA reviewed for dog products

Dexamethasone Solution NADA 200-108, Original approval, April 13, 1995; sponsor Huvepharma EOOD; species: Not stated in the FOI summary text (catalogue entry lists dogs, cats, cattle, and horses); foi_id 1344; FDA PDF

Effectiveness

No study: in vivo bioequivalence waiver granted on formulation characteristics (same active and inactive ingredients as the pioneer, injectable solution); ANADA relies on pioneer safety/effectiveness data; result: Waiver granted; product deemed safe and effective for its labeled indications by reliance on the pioneer

Based upon the formulation characteristics of the generic product, Phoenix Pharmaceutical, Inc. was granted a waiver from conducting an in vivo bioequivalence study for DEXAMETHASONE SOLUTION. The generic and pioneer products contain the same active and inactive ingredients and are administered as injectable solutions.

Extraction notes: Generic (ANADA) approval, 2-page summary. The summary text states no indication, dose regimen, or species (only the catalogue metadata mentions 'Treatment of primary bovine ketosis and as an anti-inflammatory agent in dogs, cats, cattle, and horses'), so indication and dose_regimen are null. No PK, TAS or effectiveness studies; the 'effectiveness' entry records the bioequivalence waiver only.

Dexium® NADA 200-312, Original approval, October 20, 2003; sponsor Bimeda Animal Health Ltd.; species: Bovine, equine, canine & feline; foi_id 1060; FDA PDF

Indication

Treatment of primary bovine ketosis and as an anti-inflammatory agent in the canine, feline, bovine and equine.

Dose regimen

0.25 to 1 mg (canine); 0.125 to 0.5 mg (feline), Intramuscularly or intravenously, may be repeated daily, for three (3) to five (5) days (canine and feline); equine and bovine doses (2.5 to 5 mg; 5 to 20 mg) are listed in the same dosage section

Canine - 0.25 to 1 mg intramuscularly or intravenously. The dose may be repeated for three (3) to five (5) days. Feline - 0.125 to 0.5 mg intravenously or intramuscularly. The dose may be repeated for three (3) to five (5) days.

Effectiveness

No study: in vivo bioequivalence waiver granted on formulation characteristics (injectable solution, same active ingredient/concentration/dosage form as pioneer AZIUM, NADA 12-559); result: Waiver granted; ANADA relies on pioneer safety and effectiveness

The generic product is administered as an injectable solution, contains the same active ingredient in the same concentration and dosage form as the pioneer product, and contains no inactive ingredients that may significantly affect the absorption of the active ingredients.

Extraction notes: Generic (ANADA) approval for cattle, horses, dogs and cats; the dose field lists all species doses but only the canine and feline lines are in the quote (equine 2.5 to 5 mg and bovine 5 to 20 mg appear in the same dosage list). No PK, TAS or effectiveness studies; 'effectiveness' records the bioequivalence waiver only. Indication quote is truncated at the start to avoid a PDF-broken word ('prim ary').