Document ID: FDA-2011-N-0003-0074
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2012-02-01T05:00Z

[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Notices]
[Pages 5028-5029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0003]

Withdrawal of Approval of New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 20 new animal drug applications (NADAs) at the sponsor's request 
because the products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective February 13, 2012.

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, email: john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The following sponsors have requested that 
FDA withdraw approval of the 20 NADAs listed in table 1 of this 
document because the products are no longer manufactured or marketed:

                           Table 1--NADAs for Which Approval is Voluntarily Withdrawn
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         Application No.                    Trade name  (drug)                           Applicant
----------------------------------------------------------------------------------------------------------------
NADA 014-485....................  METOPHANE Inhalation (methoxyflurane).  Medical Developments, International
                                                                           Ltd., 556 Morris Ave., Summit, NJ
                                                                           07901-1330.
NADA 032-322....................  LIQUISONE F with Cerumene               Evsco Pharmaceuticals, an Affiliate of
                                   (hexamethyltetracosane, prednisolone,   IGI, Inc., Box 209, Harding Hwy.,
                                   tetracaine, neomycin sulfate).          Buena, NJ 08310.
NADA 044-655....................  NEOMYCANE Ophthalmic Ointment           Evsco Pharmaceuticals, an Affiliate of
                                   (neomycin sulfate).                     IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 045-288....................  OPTISONE (neomycin sulfate,             Evsco Pharmaceuticals, an Affiliate of
                                   prednisolone acetate).                  IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 049-890....................  NORCO T-2 Pre-Pak (tylosin phosphate).  Norco Mills of Norfolk, Inc., P.O. Box
                                                                           56, Norfolk, NE 68701.
NADA 055-034....................  CHLORASOL (chloramphenicol)...........  Evsco Pharmaceuticals, an Affiliate of
                                                                           IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 055-052....................  Chlora-Tabs 100 (chloramphenicol).....  Evsco Pharmaceuticals, an Affiliate of
                                                                           IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 065-158....................  CHLORICOL (chloramphenicol)...........  Evsco Pharmaceuticals, An Affiliate of
                                                                           IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 065-259....................  CHLORASONE Ophthalmic Ointment          Evsco Pharmaceuticals, an Affiliate of
                                   (chloramphenicol, prednisolone          IGI, Inc., Box 209, Harding Hwy.,
                                   acetate).                               Buena, NJ 08310.
NADA 065-488....................  BENZA-PEN (penicillin G benzathine,     Walco International, Inc., 15 West
                                   penicillin G procaine).                 Putnam, Porterville, CA 93257.

[[Page 5029]]

 
NADA 095-953....................  MOORMABOOST TY 4000 Medicated (tylosin  ADM Alliance Nutrition, Inc., 1000
                                   phosphate).                             North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 100-689....................  DIFIL Syrup (diethylcarbamazine         Evsco Pharmaceuticals, an Affiliate of
                                   citrate).                               IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 100-690....................  DIFIL Tablets (diethylcarbamazine       Evsco Pharmaceuticals, an Affiliate of
                                   citrate).                               IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 107-957....................  TYLAN 20 Sulfa-G (tylosin phosphate     ADM Alliance Nutrition, Inc., 1000
                                   and sulfamethazine).                    North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 111-069....................  TYLAN 40 Sulfa-G (tylosin phosphate     ADM Alliance Nutrition, Inc., 1000
                                   and sulfamethazine).                    North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 131-956....................  TYLAN Sulfa-G (tylosin phosphate and    ADM Alliance Nutrition, Inc., 1000
                                   sulfamethazine).                        North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 131-957....................  TYLAN 40 (tylosin phosphate)..........  ADM Alliance Nutrition, Inc., 1000
                                                                           North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 133-490....................  Ban-D-Wormer II BANMINTH (pyrantel      ADM Alliance Nutrition, Inc., 1000
                                   tartrate).                              North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 140-842....................  HYGROMIX 2.4 Premix (hygromycin B)....  ADM Alliance Nutrition, Inc., 1000
                                                                           North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 140-958....................  EQUIPHEN Paste (phenylbutazone).......  Luitpold Pharmaceuticals, Inc., Animal
                                                                           Health Division, Shirley, NY 11967.
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    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 
014-485, 032-322, 044-655, 045-288, 049-890, 055-034, 055-052, 065-158, 
065-259, 065-488, 095-953, 100-689, 100-690, 107-957, 111-069, 131-956, 
131-957, 133-490, 140-842, and 140-958, and all supplements and 
amendments thereto, is hereby withdrawn, effective February 13, 2012.
    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 applications.

    Dated: January 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-2109 Filed 1-31-12; 8:45 am]
BILLING CODE 4160-01-P