... [Federal Register: May 12, 2010 (Volume 75, Number 91 )] [Rules and Regulations] [Page 26647] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID: fr12my10-4]-DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA-2010-N-0002] Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin 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) filed by Sparhawk Laboratories, Inc. The ANADA provides for use of an ivermectin injectable solution in cattle and swine for treatment and control of various internal and external parasites. DATES: This rule is effective May 12, 2010. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-170 ), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240-276-8197, e-mail: john.harshman @fda.hhs.gov. SUPPLEMENTARY INFORMATION ...

... [Federal Register: May 12, 2010 (Volume 75, Number 91 )] [Rules and Regulations] [Page 26647-26648] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID: fr12my10-5]-DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 [Docket No. FDA-2010-N-0002] Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule, technical amendment.-SUMMARY: 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 First Priority, Inc. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin. DATES: This rule is effective May 12, 2010. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-170 ), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240-276-8197, e-mail ...