01-20574. EVSCO Pharmaceuticals, an Affiliate of IGI, Inc.; Withdrawal of Approval of NADAs

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) held by EVSCO Pharmaceuticals, an Affiliate of IGI, Inc. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove the portions reflecting approval of the NADAs because these products are no longer manufactured or marketed.

DATES:

Withdrawal of approval is effective August 27, 2001.

FOR FURTHER INFORMATION CONTACT:

Pamela K. Esposito, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5593.

SUPPLEMENTARY INFORMATION:

EVSCO Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310, has requested that FDA withdraw approval of NADA 32-984 for Cerumite (chloramphenicol, prednisolone, tetracaine, and squalane) topical suspension, and NADA 55-005 for Liquichlor with Cerumene (squalane, pyrethrins, and piperonyl butoxide) topical suspension because the products are no longer manufactured or marketed.

Therefore, under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary Medicine (21 CFR 5.84), and in accordance with § 514.115 Withdrawal of approval of applications (21 CFR 514.115), notice is given that approval of NADAs 32-984 and 55-005 and all supplements and amendments are withdrawn effective August 27, 2001.

In a final rule published elsewhere in this issue of the Federal Register, the agency is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs.

Dated: August 6, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.