[Federal Register Volume 60, Number 31 (Wednesday, February 15, 1995)]
[Notices]
[Pages 8661-8662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3801]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0450]
Premiere Agri Technologies, Inc., et al.; Withdrawal of Approval
of NADA's
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing
[[Page 8662]] approval of five new animal drug applications (NADA's),
one held by Pfizer, Inc., and four NADA's held by Premiere Agri
Technologies, Inc. Pfizer, Inc., notified FDA that its oxytetracycline
soluble powder is no longer marketed. Premiere Agri Technologies, Inc.,
notified FDA that its approved NADA's are no longer required to
manufacture Type B medicated feeds containing tylosin or virginiamycin.
For these reasons, both sponsors 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applications be withdrawn.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 27, 1995.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722.
SUPPLEMENTARY INFORMATION: FDA has been informed by : (1) Pfizer, Inc.,
that it is no longer manufacturing or marketing its oxytetracycline
soluble powder, and (2) Premiere Agri Technologies, Inc., that approval
of its NADA's listed in the table is no longer required to manufacture
Type B medicated feeds containing tylosin or virginiamycin (Type A
medicated articles containing tylosin are covered by another NADA).
Accordingly, both firms requested in writing that FDA withdraw approval
of the applications.
------------------------------------------------------------------------
Sponsor name and
NADA No. Drug name address
------------------------------------------------------------------------
10-661................. Oxytetracycline soluble Pfizer, Inc., 235 East
powder 42d St., New York, NY
(Terramycin 10017
Egg Formula).
45-690................. Tylosin Type B Premiere Agri
medicated feeds and Technologies, Inc.,
Type A medicated P.O. Box 2508, Fort
article. Wayne, IN 46801-2508
(former sponsor
Henwood Feed
Additives)
97-289................. Tylosin Type B Do. (Former sponsor
medicated feeds and Feed Specialties Co.,
Type A medicated Inc.)
article.
133-361................ Virginiamycin Type B Do. (Former sponsor
medicated feed. Feed Specialties Co.,
Inc.)
133-839................ Virginiamycin Type B Do. (Former sponsor
medicated feed. MAC-PAGE, Inc.)
------------------------------------------------------------------------
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 10-661, 45-690, 97-289, 133-361, and 133-839 and all
supplements and amendments thereto is hereby withdrawn, effective
February 27, 1995.
In a final rule published elsewhere in this issue of the Federal
Register, FDA is: (1) Amending 21 CFR 558.625 by removing and reserving
paragraphs (b)(11) and (b)(15) to reflect the withdrawal of approval of
NADA's 45-690 and 97-289 and (2) amending 21 CFR 558.635(b)(2) to
reflect the withdrawal of approval of NADA's 133-361 and 133-839. It is
unnecessary to amend the regulations to reflect withdrawal of approval
of NADA 10-661 because it is not codified.
Dated: January 6, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-3801 Filed 2-14-95; 8:45 am]
BILLING CODE 4160-01-F
