Animal drugs, feeds, and related products: New drug applications— Ivermectin liquid,

[Federal Register: July 17, 1998 (Volume 63, Number 137)]

[Rules and Regulations]

[Page 38473-38474]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr17jy98-9]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; Ivermectin Liquid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filedby Phoenix Scientific, Inc. The ANADA provides for veterinary prescription use of ivermectin oral liquid in horses to treat and control parasites and parasitic conditions.

EFFECTIVE DATE: July 17, 1998.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filedANADA 200- 202 that provides for veterinary prescription use of Phoenectin‹SUP›TM‹/SUP› Liquid (10 milligram per milliliter (mg/mL) ivermectin oral liquid) for horses for the treatment and control of infections of large strongyles (adult) (Strongylus equinus), (adult and arterial larval stages) (S. vulgaris), (adult and migrating tissue stages) (S. endentatus), (adult) (Triodontophorus spp.); small strongyles, including those resistant to some benzimidizole class compounds (adults and fourth-stage larvae) (Cyathostomum spp.,

[[Page 38474]]

Cylicocyclus spp., Cylicodontophorus spp., (Cylicostephanus spp.), pinworms (adult and fourth-stage larvae) (Oxyuris equi); ascarids (third- and fourth-stage larvae and adults) (Parascaris equorum); hairworms (adult) (Trichostrongylus axei); large-mouth stomach worms (adult) (Habronema muscae); stomach bots (oral and gastric stages) (Gastrophilus spp.); lungworms (adults and forth-stage larvae) (Dictyocaulus arnfieldi); intestinal threadworms (adults) (Strongyloides westeri); summer sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; and dermatitis caused by neck threadworm microfilariae (Onchocerca spp.).

Approval of ANADA 200-202 for Phoenix Scientific, Inc.'s, ivermectin oral liquid is as a generic copy of Merial Ltd.'s, NADA 140- 439 Eqvalan ‹Register› (ivermectin) liquid for horses. The ANADA is approved as of June 5, 1998, and the regulations are amended in 21 CFR 520.1195(b) to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and Sec. 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

   Authority: 21 U.S.C. 360b.

   Sec. 520.1195 [Amended]

2. Section 520.1195 Ivermectin liquid is amended in paragraph (b) by removing ``No. 050604'' and adding in its place ``Nos. 050604 and 059130''.

   Dated: July 9, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

   [FR Doc. 98-19028Filed7-16-98; 8:45 am]

   BILLING CODE 4160-01-F