Date of Approval: December 18, 2008
I. GENERAL INFORMATION
- File Number: ANADA 200-286
IVX Animal Health, Inc.
3915 South 48th Street Ter.
St. Joseph, MO 64503
Drug Labeler Code: 059130
- Established Name: Ivermectin
- Proprietary Name: PHOENECTIN Paste 1.87%
- Dosage Form: Oral Paste
- How Supplied: 6.08 g and 7.30 g sizes in IVX-style and Sure-Grip style syringes
- How Dispensed: OTC
- Amount of Active Ingredients: 1.87% ivermectin
- Route of Administration: Oral
- Species/Class: Horses, not for meat production
- Recommended Dosage: Each syringe contains sufficient paste to treat five 1,250 lb horses or a total of 6,250 lb body weight at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) of body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight.
- Pharmacological Category: Antihelmintic and boticide
- Indications: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. PHOENECTIN (ivermectin) Paste 1.87% provides effective treatment and control of the following parasites in horses. Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) – Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum; Small Strongyles – Fourth-stage larvae; Pinworms (adults and fourth-stage larvae) – Oxyuris equi, Ascarids (adults and third-and fourth-stage larvae) – Parascaris equorum; Hairworms (adults) – Trichostrongylus axei; Large-mouth Stomach Worms (adults) – Habronema muscae; Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) – Dictyocaulus arnfieldi; Intestinal Threadworms (adults) – Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third- stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
- Pioneer Product: EQVALAN Paste 1.87%; ivermectin; NADA 134-314; Merial Ltd.
- Effect of Supplement: This supplement requests the addition of labeling claims that are no longer protected by marketing exclusivity for the following parasite species: Craterostomum acuticaudatum, Coronocyclus coronatus, Coronocyclus labratus and Petrovinema poculatum.
II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS
Refer to the original Freedom of Information (FOI) Summary (ANADA 200-286, E-0002) dated September 20, 2000, for more detail.
III. HUMAN SAFETY
This drug is intended for use in horses, which are non-food animals. Because this new animal drug is not intended for use in food-producing animals, data on human safety pertaining to drug residues in food were not required for approval of this ANADA.
Human warnings are provided on the product label as follows: “Not for use in humans. Keep this and all drugs out of the reach of children. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes.
IV. AGENCY CONCLUSIONS
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that PHOENECTIN Paste 1.87%, when used under the proposed conditions of use, is safe and effective for its labeled indications.
Facsimile Generic Labeling and Currently Approved Pioneer Labeling are attached as indicated below:
- Generic Labeling:
- Syringe label;
- package insert;
- carton label;
- display tray
- Pioneer Labeling:
- Syringe label;
- package insert;
- carton label