FREEDOM OF INFORMATION SUMMARY
1. GENERAL INFORMATION:
ANADA: 200-202
Sponsor:
Phoenix Scientific, Inc.
3915 South 48th Street Terrace
P.O. Box 6457
St. Joseph, MO 64506-0457
Generic Name: Ivermectin Oral Liquid
Trade Name: Phoenectin TM Liquid for Horses
Dosage Form: Oral Solution
How Supplied: 100 mL Bottles
How Dispensed: Rx
Amount of Active Ingredients: 10.0 mg/mL
Route of Administration: Oral
Species: Horses
Labeled Dosage: 200 mcg/kg of body weight (1 mL/110 lb (50 kg) body weight)
Indications for Use:
Phoenectin TM (ivermectin) Liquid is indicated for the effective treatment and control of the following parasites or parasitic conditions in horses:
Large Strongyles:
Strongylus vulgaris (adults and arterial larval stages)
S.edentatus (adults and tissue stages)
S.equinus (adults)
Triodontophorus spp (adults)
Small Strongyles - including those resistant to some benzimidizole class compounds (adults and fourth-stage larvae):
Cyanthostomum spp
Cylicocyclus spp
Cylicostephanus spp
Cylicodontophorus spp
Pinworms
(adults and fourth-stage larvae)
Oxyuris equi
Ascarids
(adults and third- and fourth-stage larvae)
Parascris equorum
Hairworms
(adults):
Trichostrongylus axei
Large-mouth Stomach Worms
(adults): Habronema muscae
Bots
(oral and gastric stages):
Gastrophilus spp
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 spp.
Pioneer Product/ Eqvalan® Liquid for Horses (Ivermectin)
"Listed Product: ® NADA 140-439 (Merial Ltd.)
2. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS:
Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA approval is based on a demonstration that the generic product is bioequivalent to the pioneer product.
Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (Fifth GADPTRA Policy Letter: 55 FR 24645, June 18, 1990; Bioequivalence Guidance: 61 FR 26182 - 26186, May 24, 1996).
Based upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver from conducting an in vivo bioequivalence study for Phoenectin TM Liquid. The generic and pioneer products contain the same active and inactive ingredients and are oral solutions.
3. HUMAN SAFETY:
Human Safety Relative to Food Consumption:
None required as Phoenectin TM Liquid is intended for use only in horses. The labeling includes the statement, "WARNING: Dot not use in horses intended for food purposes."
Human Safety Relative to Possession, Handling, and Administration:
Labeling contains adequate caution/warning statements.
4. AGENCY CONCLUSIONS:
This is an Abbreviated New Animal Drug Application (ANADA) filed under section 512(b)(2) of the Federal, Food, Drug and Cosmetic (FFD&C) Act.
Safety and effectiveness for this generic animal drug, Phoenectin TM Liquid, were established by demonstration of chemical equivalence to the pioneer product, Eqvalan® Liquid for Horses (NADA 140-439, Merial Ltd).
This generic product and the pioneer product have identical labeling indications for use in horses. The route and method of administration of the two drugs are identical. Both drugs are administered orally. The generic and pioneer products contain the same active and inactive ingredients. Therefore, in compliance with FDA policy implementing section 512(b)(2) of FFD&C Act in vivo bioequivalency studies were not necessary nor required.
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that Phoenectin TM Liquid, is safe and effective for its labeled indications when used under it proposed conditions of use.
Attachments:
1. Generic Labeling:
Package Insert
Bottle Label
2. Pioneer Labeling
Package Insert
Bottle Label
Carton Label
