[Federal Register Volume 76, Number 62 (Thursday, March 31, 2011)]
[Notices]
[Pages 17927-17928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7558]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0151]
Withdrawal of Approval of New Animal Drug Applications; Chorionic
Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole;
Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and
Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 13 new animal drug applications (NADAs). In a final rule published
elsewhere in this issue of the Federal Register, FDA is amending the
regulations to remove portions reflecting approval of these NADAs.
DATES: Withdrawal of approval is effective April 11, 2011.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: The sponsors of the 13 approved NADAs listed
in table 1 have requested that FDA withdraw approval because the
products are no longer manufactured or marketed.
Table 1--Voluntary Requests for Withdrawal of Approval of 13 NADAs
----------------------------------------------------------------------------------------------------------------
NADA No. Product (Established 21 CFR Section Affected (Sponsor's Drug
Sponsor Name of Drug) Labeler Code)
----------------------------------------------------------------------------------------------------------------
Roche Vitamins, Inc., 45 Waterview NADA 093-029.................. 524.520
Blvd., Parsippany, NJ 07054-1298. UNITOP Cream.................. (063238)
(cuprimyxin)..................
Quali-Tech Products, Inc., 318 Lake NADA 097-981.................. 558.630
Hazeltine Dr., Chaska, MN 55318. TYLAN 40 Sulfa-G Premix....... (016968)
(tylosin phosphate/
sulfamethazine).
Abraxis Pharmaceutical Products, NADA 100-840.................. 522.1081
Division of Abraxis Bioscience, 6133 Chorionic Gonadotropin for (063323)
River Rd., suite 500, Rosemont, IL Injection.
60018. (chorionic gonadotropin)......
Furst-McNess Co., Freeport, IL 61032.. NADA 100-991.................. 558.625
McNess Custom Premix L200..... (010439)
(tylosin phosphate)...........
Fort Dodge Animal Health, Division of NADA 101-079.................. Not codified
Wyeth Holdings, a wholly owned TRAMISOL-10% Pig Wormer....... (000856)
subsidiary of Pfizer, Inc., 235 East (levamisole)..................
42d St., New York, NY 10017.
Waterloo Mills Co., 2050 Mitchell NADA 101-905.................. 558.625
Ave., Waterloo, IA 50704. Mill Co-Medicator TY-10....... (017139)
(tylosin phosphate)...........
Waterloo Mills Co., 2050 Mitchell NADA 101-906.................. 558.630
Ave., Waterloo, IA 50704. Mill Co-Medicator TS-40 Premix (017139)
(tylosin phosphate/
sulfamethazine).
Pegasus Laboratories, Inc., 8809 Ely NADA 102-824.................. 520.1720a
Rd., Pensacola, FL 32514. Phenylbutazone Tablets........ (055246)
(phenylbutazone)..............
Wendt Laboratories, Inc., 100 Nancy NADA 108-487.................. 520.622a
Dr., Belle Plaine, MN 56011. DEC Tabs...................... (015579)
(diethylcarbamazine citrate)..
Wendt Laboratories, Inc., 100 Nancy NADA 108-863.................. 520.622c
Dr., Belle Plaine, MN 56011. DEC Chewable Tabs............. (015579)
(diethylcarbamazine citrate)..
Furst-McNess Co., Freeport, IL 61032.. NADA 140-820.................. 558.630
TYLAN 40 Sulfa-G Premix....... (010439)
(tylosin phosphate/
sulfamethazine).
Furst-McNess Co., Freeport, IL 61032.. NADA 140-825.................. 558.485
BANMINTH Intermediate Premix.. (010439)
(pyrantel tartrate)...........
Hess & Clark, Inc., 944 Nandino Blvd., NADA 140-910.................. 524.1580c
Lexington, KY 40511. NFZ Wound Powder.............. (050749)
(nitrofurazone)...............
----------------------------------------------------------------------------------------------------------------
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
93-029, 97-981, 100-840, 100-991, 101-079, 101-905, 101-906, 102-824,
108-487, 108-863, 140-820, 140-825, and 140-910, and all supplements
and amendments thereto, is hereby withdrawn, effective April 11, 2011.
[[Page 17928]]
In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending the animal drug regulations to reflect the
withdrawal of approval of these NADAs.
Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7558 Filed 3-30-11; 8:45 am]
BILLING CODE 4160-01-P