[Federal Register Volume 62, Number 139 (Monday, July 21, 1997)]
[Notices]
[Pages 39001-39002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19065]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0215]
Babineaux's Veterinary Products, 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 one new animal drug application (NADA) held by Babineaux's
Veterinary Products, Inc., and two NADA's held by Schein
Pharmaceutical, Inc. / Steris Laboratories, Inc. The sponsors requested
voluntary withdrawal of approval of the NADA's because the products are
no longer being marketed. In a final rule published elsewhere in this
issue of the Federal Register, FDA is amending the regulations by
removing those portions which reflect approval of these NADA's.
EFFECTIVE DATE: July 31, 1997
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722.
SUPPLEMENTARY INFORMATION: Babineaux's Veterinary Products, Inc., 6425
Airline Hwy., Metairie, LA 70003, is the sponsor of NADA 46-147
Dirocide (diethylcarbamazine citrate) Syrup. Schein Pharmaceutical,
Inc. / Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ
85043-4705, is the sponsor of NADA 48-391 phenylbutazone injection and
NADA 49-183 oxytocin injection. The sponsors requested withdrawal of
approval of the NADA's under 21 CFR 514.115(d) because the products are
no longer being 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 Sec. 514.115 Withdrawal
of approval of applications (21 CFR 514.115), notice is given that
approval of NADA's 46-147, 48-391, and 49-183 and all supplements and
amendments thereto is hereby withdrawn, effective July 31, 1997.
In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending 21 CFR 510.600, 520.622b, 522.1680, and
522.1720 to reflect
[[Page 39002]]
withdrawal of approval of these NADA's.
Dated: July 11, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-19065 Filed 7-18-97; 8:45 am]
BILLING CODE 4160-01-F
