77 FR 21 pgs. 5028-5029 - Withdrawal of Approval of New Animal Drug Applications
Type: NOTICEVolume: 77Number: 21Pages: 5028 - 5029
Docket number: [Docket No. FDA-2011-N-0003]
FR document: [FR Doc. 2012-2109 Filed 1-31-12; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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:
| 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 (hexamethyltetracosane, prednisolone, tetracaine, neomycin sulfate) | Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 044-655 | NEOMYCANE Ophthalmic Ointment (neomycin sulfate) | Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 045-288 | OPTISONE (neomycin sulfate, prednisolone acetate) | Evsco Pharmaceuticals, an Affiliate of 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 (chloramphenicol, prednisolone acetate) | Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 065-488 | BENZA-PEN (penicillin G benzathine, penicillin G procaine) | Walco International, Inc., 15 West Putnam, Porterville, CA 93257. |
| NADA 095-953 | MOORMABOOST TY 4000 Medicated (tylosin phosphate) | ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115. |
| NADA 100-689 | DIFIL Syrup (diethylcarbamazine citrate) | Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 100-690 | DIFIL Tablets (diethylcarbamazine citrate) | Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 107-957 | TYLAN 20 Sulfa-G (tylosin phosphate and sulfamethazine) | ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115. |
| NADA 111-069 | TYLAN 40 Sulfa-G (tylosin phosphate and sulfamethazine) | ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115. |
| NADA 131-956 | TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) | ADM Alliance Nutrition, Inc., 1000 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 tartrate) | ADM Alliance Nutrition, Inc., 1000 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. |
Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 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]
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