Document ID: FDA-2011-N-0161-0001
Agency: fda
Document Type: Notice
Title: Withdrawals of Approvals; New Animal Drug Applications:
Posted Date: 2011-03-31T04:00Z

[Federal Register: March 31, 2011 (Volume 76, Number 62)]
[Notices]               
[Page 17927-17928]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr11-70]                         

-----------------------------------------------------------------------

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: john.bartkowiak@fda.hhs.gov.

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