Withdrawal of Approval of New Animal Drug Applications; Dichlorophene and Toluene Capsules
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) for use of dichlorophene and toluene deworming capsules for cats and dogs. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations to remove portions reflecting approval of these NADAs.
Withdrawal of approval is effective September 7, 2010.
For further information contact:
John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079; email:firstname.lastname@example.org.
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 has requested that FDA withdraw approval of NADA 101-497 for TINY TIGER (dichlorophene/toluene) Worming Capsules, NADA 101-498 for LK (dichlorophene/toluene) Worming Capsules because they are no longer manufactured or marketed.
Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116Notice of withdrawal of approval of application(21 CFR 514.116), notice is given that approval of NADAs 101-497 and 101-498, and all supplements and amendments thereto, is hereby withdrawn, effective September 7, 2010.
In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs.Dated: August 23, 2010. Bernadette Dunham, Director, Center for Veterinary Medicine.