[Federal Register Volume 60, Number 238 (Tuesday, December 12, 1995)]
[Notices]
[Pages 63720-63721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30122]
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[[Page 63721]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0346]
Akorn, 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 five new animal drug applications (NADA's). Three NADA's are held by
Akorn, Inc., and one each is held by Parke-Davis, Division of Warner-
Lambert Co., and Veterinary Research and Development, Inc. The firms
notified the agency in writing that the animal drug products were 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withdrawn.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: December 22, 1995.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0159.
SUPPLEMENTARY INFORMATION: The sponsors of the applications listed in
the table in this document have informed FDA that these animal drug
products are no longer marketed and have requested that FDA withdraw
approval of the applications.
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Sponsor name and
NADA No. Drug name address
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6-032.......................... Diphenylhydantoin Parke-Davis,
sodium capsules. Division of
Warner-Lambert
Co., 201 Tabor
Rd., Morris
Plains, NJ 07950
12-444......................... Sterile Akorn, Inc., 100
prednisolone Akorn Dr., Abita
suspension. Springs, LA 70420
94-978......................... Phenylbutazone Do.
injection.
110-046........................ Dexamethasone Do.
injection.
140-904........................ Copper disodium Veterinary
edetate injection. Research and
Development,
Inc., P.O. Box
1299, Truckee, CA
95734
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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 6-032, 12-444, 94-978, 110-046, and 140-904 and all
supplements and amendments thereto is hereby withdrawn, effective
December 22, 1995.
In a final rule published elsewhere in this issue of the Federal
Register, FDA is removing 21 CFR 520.704, 522.514, and 522.1880, and
amending 21 CFR 510.600(c), 522.540, and 522.1720 to reflect the
withdrawal of approval of the above mentioned NADA's.
Dated: December 4, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-30122 Filed 12-11-95; 8:45 am]
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