Veterinary pharmaceuticals (veterinary drugs) are those products which achieve their effect through chemical reaction or metabolism in the body. This mechanism of action distinguishes veterinary pharmaceuticals from veterinary medical devices or veterinary biologics. In addition to the mechanism of action, the distinction between a veterinary drug and veterinary biologic is also related to it’s intended use. Before beginning the process of developing a product for veterinary medicine, it is very important to understand how a product will be regulated as the development process and manufacturing requirements can be very different among the various agencies that regulate veterinary products.
Veterinary Pharmaceuticals
Veterinary Drugs and Veterinary Pharmaceuticals
Developing Veterinary Drugs
There are a variety of steps to developing veterinary drugs / veterinary pharmaceuticals. Woods Consulting, LLC can assist companies in opening and Investigational New Animal Drug file (INAD), and reviewing the fees associated with New Animal Drug Applications as described in the Animal Drug User Fee Act (ADUFA).
Examples
- Antibiotics and antifungals
- Athelmintics (antiparasitics)
- Non-steroidal anti-inflammatories (NSAIDs)
- Steroids
New Animal Drug Applications (NADA): at a minimum, the following technical sections are a component the submission of a veterinary drug master file.
- Target Animal Safety
- Substantial Evidence – Target Animal Efficacy
- Human Food Safety
- Chemistry, Manufacturing and Controls
- Environmental Impact
Regulatory Links
- USA: Food and Drug Administration.
- Europe: European Medicines Agency
- Canada: Veterinary Drugs Directorate.
Veterinary Pharmaceutical Regulations
General Overview of Veterinary Drug Regulations
In the United States, veterinary drugs are subject to the Food, Drug and Cosmetics Act and must receive an approval from the FDA-CVM before they can legally marketed. Before entering confirmatory veterinary clinical trials in support of an approval (New Animal Drug Application or NADA), Sponsors must open an Investigational New Animal Drug Application and obtain a Notice of Claimed Investigational Exemption (NCIE). The veterinary clinical trials should be designed to support the label claims, and meet the criteria for evidencing substantial evidence of safety and efficacy (often referred to as target animal safety studies and target animal efficacy studies). In addition, there are very specific requirements on the manufacturing of products, such as applying Good Manufacturing Practices, and there can be different requirements for labeling and reporting adverse events.
Extralabel use of FDA approved Drugs in Veterinary Medicine:
Veterinarians are also permitted to prescribe, under extralabel use, certain approved new animal drugs and approved human drugs according to the Animal Medicinal Drug Use Clarification Act (AMDUCA). Veterinary extralabel use of drugs approved by the FDA is defined as “Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses.”
Veterinary Pharmaceuticals Regulated Under Minor Use Minor Species (MUMS) Act
MUMS is the pathway for veterinary drug development designed specifically for the minor use in a major species or for minor species. Minor use in a major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) are veterinary drugs intended to be developed for diseases that have low incidence or prevalent, or for diseases that found only in a limited geographical area. Minor species are those non-human animals that are not major species (listed above), such as exotic animals, zoo animals, ferrets, etc. Link to FDA MUMS page.
The specific number of animals that are considered the maximum threshold for MUMS designation are as follows (by species).
- Dogs: 70,000
- Cats: 120,000
- Horses: 50,000
- Cattle: 310,000
- Pigs: 1,450,000
NOTE: the FDA periodically reviews the MUMS requirements, and the above numbers are subject to change.
Animal Drug User Fee Act
(ADUFA)
ADUFA was established in 2003 to allow the FDA to secure fees for animal drug applications, products, establishments and veterinary drug sponsors. The fees collected by the FDA are amended on an annual or less frequent basis. Waivers or reductions in ADUFA fees may be granted under certain conditions; including:
- ADUFA fees would represent a significant barrier to innovation. For instance, would the ADUFA fees result in financial constraints that would prohibit further development by the applicant.
- The animal drug application (including supplemental applications) is intended for minor use or minor species indications.
- The application represents the first (initial) application submitted by a small business or its affiliate.
More information on ADUFA fees and waiver can be found here:
CVM-GFI–170-Animal-Drug-User-Fees-and-Fee-Waivers-and-Reductions
Link to FDA ADUFA page
Veterinary Drug Registration Outside of the United States
Veterinary drugs being developed for sale and distribution in foreign countries are subject to different regulatory agencies. The following provides a few resources concerning foreign oversight for veterinary pharmaceuticals and veterinary drug development.
- Europe: European Medicines Agency
- Canada: Veterinary Drugs Directorate
- Japan: Ministry of Agriculture, Forestry and Fisheries
List of Approved Veterinary Pharmaceuticals (veterinary drugs)
The following dropdowns provide a list of FDA-CVM approved veterinary drugs by ingredient. This list of veterinary pharmaceuticals is current as of Sep 2024 and is derived from publicly available information.
- A-F
Acepromazine Maleate
Acetazolamide Sodium
Acetylsalicylic Acid
Afoxolaner
Albendazole
Alfaxalone
Altrenogest
Amikacin Sulfate
Aminopentamide Hydrogen Sulfate
Aminopropazine Fumarate
Amitraz
Ammonium Chloride
Amoxicillin
Amoxicillin Trihydrate
Amphomycin Calcium
Ampicillin Anhydrous
Ampicillin Sodium
Ampicillin Trihydrate
Amprolium
Apramycin Sulfate
Atipamezole Hydrochloride
Atropine
Attapulgite
Avilamycin
Azaperone
Bacitracin
Bacitracin methylenedisalicylate
Bacitracin Zinc
Balsam Peru Oil
Bambermycins
Bc2371 rDNA construct
Bedinvetmab
Benazepril hydrochloride
Betamethasone Acetate
Betamethasone Dipropionate
Betamethasone Sodium Phosphate
Betamethasone Valerate
Bexagliflozin
Bismuth Subcarbonate
Boldenone Undecylenate
Bovine Somatotropin (Sometribove Zinc)
Bunamidine Hydrochloride
Bupivacaine
Buprenorphine
Butacaine Sulfate
Butamisole Hydrochloride
Butorphanol Tartrate
Capromorelin
Caramiphen Edisylate
Carbadox
Carbomycin
Carnidazole
Carprofen
Castor Oil
Cefadroxil
Cefovecin sodium
Cefpodoxime proxetil
Ceftiofur Crystalline Free Acid
Ceftiofur Hydrochloride
Ceftiofur Sodium
Cephalexin
Cephapirin Benzathine
Cephapirin Sodium
Chloral Hydrate
Chloramine-T trihydrate
Chloramphenicol
Chloramphenicol Palmitate
Chlorhexidine Acetate
Chlorhexidine Hydrochloride
Chlorobutanol
Chloroquine Phosphate
Chlorphenesin Carbamate
Chlortetracycline
Chlortetracycline Bisulfate
Chlortetracycline Calcium Complex
Chlortetracycline Hydrochloride
Chorionic Gonadotropin
Chymotrypsin
Ciclesonide
Citric Acid
Clavulanate Potassium
Clenbuterol Hydrochloride
Clindamycin
Clindamycin Hydrochloride
Clodronate
Clomipramine Hydrochloride
Clopidol
Cloprostenol Sodium
Clorsulon
Clotrimazole
Cloxacillin Benzathine
Cloxacillin Sodium
Colistimethate Sodium
Colloidal Ferric Oxide
Copper carbonate
Copper Naphthenate
Corticotropin
Coumaphos
Crofelemer
Cyclosporine
Cyclosporine oral solution, USP Modified
Cythioate
Danofloxacin
Decoquinate
Deracoxib
Deslorelin Acetate
Desoxycorticosterone Pivalate
Detomidine Hydrochloride
Dexamethasone
Dexamethasone Sodium Phosphate
Dexmedetomidine
Dexmedetomidine hydrochloride
Dextrose
Diatrizoate Meglumine
Diatrizoate Sodium
Dibucaine Hydrochloride
Dichlorophene
Dichlorvos
Diclazuril
Diclofenac sodium
Dicloxacillin Sodium Monohydrate
Diethylcarbamazine Citrate
Dihydrostreptomycin Sulfate
Dimethyl Sulfoxide
Dinoprost Tromethamine
Diprenorphine Hydrochloride
Dipyrone
Dirlotapide
Dithiazanine Iodide
domperidone
Doramectin
Doxycycline Hyclate
Doxylamine Succinate
Droperidol
Efrotomycin
Embutramide
Emodepside
Enrofloxacin
Eprinomectin
Epsiprantel
Erythromycin
Erythromycin Phosphate
Erythromycin Thiocyanate
Esafoxolaner
Estradiol
Estradiol Benzoate
Estradiol Valerate
estriol
Ethopabate
Ethylisobutrazine Hydrochloride
Etorphine Hydrochloride
Famphur
Febantel
Fenbendazole
Fenprostalene
Fentanyl Citrate
Fenthion
Firocoxib
Florfenicol
Flumethasone
Flumethasone Acetate
Flunixin
Flunixin Meglumine
Fluocinolone Acetonide
Fluoxetine hydrochloride
Fluprostenol Sodium
Fluralaner
Follicle Stimulating Hormone
Formalin
Frunevetmab
Furazolidone
Furosemide
Fuzapladib sodium
- G-L
Gamithromycin
Gelatin
Gentamicin Sulfate
Gleptoferron
Glycine
Glycopyrrolate
Gonadorelin
Gonadorelin acetate
Gonadorelin Hydrochloride
Gonadotropin Releasing Factor – Diphtheria Toxoid conjugate
Grapiprant
Griseofulvin
Guaifenesin
Halofuginone Hydrobromide
Halothane
Haloxon
Helium, USP
Hemoglobin Glutamer-200 (bovine)
Hetacillin Potassium
hLAL rDNA construct
Hyaluronate Sodium
Hydrocortisone
Hydrocortisone aceponate
Hydrocortisone Acetate
Hydrogen Peroxide
Hygromycin B
Ilunocitinib
Imepitoin
Imidacloprid
Imidocarb Dipropionate
Insulin
Iodinated Casein
Iodochlorhydroxyquin
Iron Dextran Complex
Isoflupredone Acetate
Isoflurane
Isopropamide Iodide
Itraconazole
Ivermectin
Kanamycin Sulfate
Ketamine Hydrochloride
Ketoprofen
Laidlomycin Propionate Potassium
Lasalocid
Lasalocid sodium
Levamisole
Levamisole Hydrochloride
Levamisole Phosphate
Levamisole Resinate
Levothyroxine sodium
Lidocaine
Lincomycin
Lincomycin Hydrochloride
Lincomycin Hydrochloride Monohydrate
Liothyronine Sodium
Lotilaner
Lubabegron
Lufenuron
Luprostiol
- M-R
Maduramicin Ammonium
Magnesium Sulfate
Manganese carbonate
Marbofloxacin
Maropitant
Mebendazole
Meclofenamic Acid
Medetomidine
Medetomidine hydrochloride
Megestrol Acetate
Melarsomine Dihydrochloride
Melatonin
Melengestrol Acetate
Meloxicam
Mepivacaine Hydrochloride
Mercaptobenzothiazole (2-Mercaptobenzothiazole)
Methenamine Mandelate
Methimazole
Methocarbamol
Methylprednisolone
Methylprednisolone Acetate
Metoserpate Hydrochloride
Metronidazole
Mibolerone
Miconazole Nitrate
Milbemycin Oxime
Mirtazapine
Molidustat
Mometasone furoate
Mometasone Furoate Monohydrate
Monensin
Monensin Sodium
Monensin USP
Morantel Tartrate
Moxidectin
Mupirocin
Naltrexone Hydrochloride
Naproxen
Narasin
N-butyl Chloride
N-Butylscopolammonium bromide
Neomycin Palmitate
Neomycin Sulfate
Neostigmine Methylsulfate
Nicarbazin
Nitenpyram
Nitrofurazone
Nitrous Oxide, USP
Norgestomet
Novobiocin
Novobiocin Sodium
Nystatin
Oclacitinib
Oleate Sodium
Omeprazole
opAFP-GHc2 rDNA construct
Orbifloxacin
Ormetoprim
Oxfendazole
Oxibendazole
Oxytetracycline
Oxytetracycline (Monoalkyl Trimethyl Ammonium Salt)
Oxytetracycline Dihydrate
Oxytetracycline Hydrochloride
Oxytocin
Pegbovigrastim
Penicillin G Benzathine
Penicillin G Potassium
Penicillin G Procaine
Pentazocine Lactate
Pentobarbital
Pentobarbital Sodium
Pentosan polysulfate sodium
Pergolide mesylate
Phenobarbital
Phenothiazine
Phenylbutazone
Phenylpropanolamine hydrochloride
Phenytoin Sodium
Phosmet
Pimobendan
Piperazine Citrate
Piperazine Dihydrochloride
Piperazine Monohydrochloride
Piperazine Phosphate
Piperazine-carbon Disulfide Complex
Pirlimycin Hydrochloride
Pituitary Luteinizing Hormone
Poloxalene
Polymyxin B Sulfate
Polysulfated Glycosaminoglycan
Ponazuril
Porcine insulin zinc suspension
Porcine pituitary-derived follicle stimulating hormone
posaconazole
Potassium bromide
Potassium Citrate
Potassium Phosphate
pPL657 rDNA construct
Pradofloxacin
Pralidoxime Chloride
Praziquantel
Prednisolone
Prednisolone Acetate
Prednisolone Sodium Phosphate
Prednisolone Sodium Succinate
Prednisone
Pregabalin
Primidone
Prochlorperazine Dimaleate
Prochlorperazine Edisylate
Prochlorperazine Maleate
Progesterone
Promazine Hydrochloride
Proparacaine Hydrochloride
Propiopromazine Hydrochloride
Propofol
Prostalene
Pyrantel Pamoate
Pyrantel Tartrate
Pyrilamine Maleate
Pyrimethamine
Rabacfosadine
Ractopamine Hydrochloride
Robenacoxib
Robenidine Hydrochloride
Romifidine hydrochloride
Ropinirole
- S-Z
Salinomycin Sodium
Sarolaner
Secobarbital Sodium
Selamectin
Selegiline Hydrochloride
Selenium Disulfide
Semduramicin Sodium
Serum Gonadotropin
Sevoflurane
Silver sulfadiazine
Sodium Chloride
Sodium Selenite
Sodium Sulfachloropyrazine Monohydrate
Sodium sulfachlorpyridazine
Sodium sulfamethazine
Spectinomycin
Spectinomycin dihydrochloride pentahydrate
Spectinomycin Hydrochloride Pentahydrate
Spectinomycin Sulfate Tetrahydrate
Spinosad
Spironolactone
Stanozolol
Streptomycin Sulfate
Sulfachlorpyridazine
Sulfadiazine
Sulfadiazine Sodium
Sulfadimethoxine
Sulfaethoxypyridazine
Sulfamerazine
Sulfamethazine
Sulfamethazine bisulfate
Sulfamethizole
Sulfaquinoxaline
Sulfaquinoxaline sodium
Sulfisoxazole
Sulfomyxin
Telmisartan
Tepoxalin
Terbinafine
Testosterone
Testosterone Propionate
Tetracaine Hydrochloride
Tetracycline
Tetracycline Hydrochloride
Tetracycline Phosphate
Thenium Closylate
Thiabendazole
Thialbarbitone Sodium
Thiamylal Sodium
Thiopental Sodium
Thiostrepton
Thyroid Stimulating Hormone
Tiamulin
Tiamulin Hydrogen Fumarate
Ticarcillin Disodium
Tigilanol tiglate
Tildipirosin
Tiletamine Hydrochloride
Tilmicosin
Tilmicosin Phosphate
Tiludronate disodium
Tioxidazole
Toceranib Phosphate
Tolazoline Hydrochloride
Tolnaftate
Toluene
Torsemide
Trenbolone Acetate
Triamcinolone Acetonide
Tricaine Methanesulfonate
Trichlorfon
Trichlormethiazide
Triflupromazine Hydrochloride
Trilostane
Trimeprazine Tartrate
Trimethoprim
Tripelennamine Hydrochloride
Triptorelin acetate
Trypsin
Tulathromycin
Tylosin
Tylosin Phosphate
Tylosin Tartrate
Tylvalosin
Tylvalosin tartrate
Vatinoxan hydrochloride
Velagliflozin
Verdinexor
Virginiamycin
Vitamin E
Xylazine
Xylazine Hydrochloride
Yohimbine Hydrochloride
Zeranol
Zilpaterol
Zilpaterol Hydrochloride
Zinc Gluconate
Zinc oxide
Zoalene
Zolazepam Hydrochloride