[Federal Register Volume 59, Number 26 (Tuesday, February 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2755]
[[Page Unknown]]
[Federal Register: February 8, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0460]
Wyeth-Ayerst Laboratories, 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 four new animal drug applications (NADA's) held by Wyeth-Ayerst
Laboratories, Pharmachem Corp., Sanofi Animal Health, Inc., and Squire
Laboratories, Inc. The sponsors notified the agency in writing that the
animal drug products are no longer marketed and requested that approval
of the applications be withdrawn. In a final rule published elsewhere
in this issue of the Federal Register, FDA is amending the regulations
by removing the entries which reflect approval of the NADA's.
EFFECTIVE DATE: February 18, 1994
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0749.
SUPPLEMENTARY INFORMATION: The sponsors of the NADA's listed in the
table in this document have informed FDA that these animal drug
products are no longer marketed or distributed and have requested that
FDA withdraw approval of the applications.
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NADA No. Drug Sponsor
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10-783................. Promazine hydrochloride Wyeth-Ayerst
tablets. Laboratories P.O. Box
8299, Philadelphia.,
PA 19101
11-871................. Iron dextran injectable Pharmachem Corp., P.O.
Box 1035, Bethlehem,
PA 18018
132-137................ Nitrofurazone solution. Sanofi Animal Health,
Inc., 7101 College
Blvd., suite 610,
Overland Park, KS
66210
138-455................ Nitrofurazone solution. Squire Laboratories,
Inc., 100 Mill St.,
Revere, MA 02151
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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 10-783, 11-871, 132-137, and 138-455 and all
supplements and amendments thereto is hereby withdrawn, effective
February 18, 1994.
In a final rule published elsewhere in this issue of the Federal
Register, FDA is removing the text of and reserving 21 CFR 520.1962(b)
and amending 21 CFR 524.1580d(b) to reflect the withdrawal of approval
of NADA's 10-783 and 138-455, respectively. It is unnecessary to amend
the regulations to reflect withdrawal of approval of the other two
NADA's because NADA 11-871 was never codified and the sponsor of NADA
132-137 (Sanofi) has been previously removed from the regulation.
Dated: January 31, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-2755 Filed 2-7-94; 8:45 am]
BILLING CODE 4160-01-F