Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Blue Ridge Pharmaceuticals, Inc. The ANADA provides for oral use of ivermectin tablets for prevention of heartworm disease in dogs.
This rule is effective March 13, 2002.
Lonnie W. Luther, Center for Veterinary Medicine (HFV–102), Food and Drug
Blue Ridge Pharmaceuticals, Inc., 4249–105 Piedmont Pkwy., Greensboro, NC 27410, filed ANADA 200–270 that provides for veterinary prescription use of IVERHART (ivermectin) Tablets for prevention of canine heartworm disease by elimination of the tissue stage of heartworm (
In accordance with the freedom of information provisions of 21 CFR part 20 and 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.
FDA has determined under 21 CFR 25.33(d)(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.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808.
Animal drugs.
21 U.S.C. 360b.
(a)
(2) Each chewable contains 55 or 165 mcg ivermectin.
(b)
(1) No. 050604 for use of tablets or chewables described in paragraph (a)(1) as in paragraph (d)(1) and chewables described in paragraph (a)(2) as in paragraph (d)(2) of this section.
(2) No. 065274 for use of tablets described in paragraph (a)(1) as in paragraph (d)(1) of this section.
(c)
(d)
(i)
(ii)
(2)
(i)
(ii)