[Federal Register Volume 59, Number 100 (Wednesday, May 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12734]
[[Page Unknown]]
[Federal Register: May 25, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0160]
Solvay Animal Health, Inc., et al.; Withdrawal of Approval of
NADA's
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of two new animal drug applications (NADA's). One NADA is held by
Solvay Animal Health, Inc., and provides for the use of a
sulfaquinoxaline soluble powder. The other NADA is held by Pharmachem
Corp. and provides for the use of a dextran injection. The sponsors
requested withdrawal of approval of the NADA's because they no longer
manufacture or distribute the products.
EFFECTIVE DATE: June 6, 1994.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: Solvay Animal Health, Inc., 1201 Northland
Dr., Mendota Heights, MN 55120-1149, is the sponsor of NADA 7-285,
which provides for the use of Sulquin Soluble Powder
(sulfaquinoxaline sodium) in making medicated poultry and cattle
drinking water.
Pharmachem Corp., P.O. Box 1035, Bethlehem, PA 18018, is the
sponsor of NADA 12-494, which provides for use of Pharmatran (dextran
injection 6 percent) as a plasma volume expander in small and large
animals.
By letter dated August 10, 1992, Solvay Animal Health, Inc.,
requested that FDA withdraw approval of NADA 7-285 and stated that it
no longer manufactures or distributes the product. Similarly, in a
letter dated September 10, 1992, Pharmachem Corp. requested that FDA
withdraw approval of NADA 12-494 and stated that it has not marketed
its product since September 1971.
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 Sec. 514.115 Withdrawal
of approval of applications (21 CFR 514.115), notice is given that
approval of NADA's 7-285 and 12-494 and all supplements and amendments
thereto is hereby withdrawn, effective June 6, 1994.
Dated: May 18, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine
[FR Doc. 94-12734 Filed 5-24-94; 8:45 am]
BILLING CODE 4160-01-F
