# Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notification of withdrawal.
**SUMMARY:**
The Food and Drug Administration (FDA) is withdrawing approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
**DATES:**
Withdrawal of approval is effective April 21, 2014.
**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 protected]* .
**SUPPLEMENTARY INFORMATION:**
The following 5 sponsors have requested that FDA withdraw approval of the 19 NADAs listed in the following tables because the products are no longer manufactured or marketed:
• ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115:
| NADA | Product name |
| --- | --- |
| 091-582 | Gilt Edge TYLAN (tylosin phosphate) Mix. |
| 108-484 | HFA Tylosin-10 Plus Sulfa (tylosin phosphate and sulfamethazine). |
| 110-045 | Good Life TYLAN 10 (tylosin phosphate) Premix. |
| 110-439 | HFA HYGROMIX 0.48 (hygromycin B) Medicated Premix. |
| 128-411 | TYLAN 5 Sulfa (tylosin phosphate and sulfamethazine) Premix. |
• Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 79105:
| NADA | Product name |
| --- | --- |
| 138-187 | TYLAN 40 or 100 (tylosin phosphate). |
• Ridley USA, Inc. d/b/a Ridley Feed Ingredients, 1609 1st Ave., P.O. Box 110, Mendota, IL 61342:
| NADA | Product name |
| --- | --- |
| 099-468 | Waynextra for Swine (tylosin phosphate). |
| 131-958 | TYLAN Sulfa-G (tylosin phosphate and sulfamethazine). |
| 132-136 | Ban-A-Worm II (pyrantel tartrate). |
• Provimi North America, Inc., 6531 State Rte. 503, Lewisburg, OH 45338:
| NADA | Proprietary name |
| --- | --- |
| 103-089 | TYLAN 5, 10, 20, or 40 (tylosin phosphate). |
| 118-814 | WORM-BAN 5 or 10 (pyrantel tartrate). |
| 127-508 | HYGROMIX 0.6 (hygromycin B). |
| 131-413 | FLAVOMYCIN 0.4 or 2 (bambermycins). |
| 133-333 | STAFAC 10 (virginiamycin). |
• Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137:
| NADA | Proprietary name |
| --- | --- |
| 013-214 | PURINA HYGROMIX (hygromycin B) for Swine. |
| 042-660 | PURINA Pork-Plus (tylosin phosphate and sulfamethazine). |
| 043-387 | PURINA Hog Plus II (tylosin phosphate). |
| 099-767 | PURINA TYLAN 40 (tylosin) Plus Sulfamethazine. |
| 132-574 | PURINA Check-R-Ton Ll (lincomycin hydrochloride). |
[^1] The NADAs listed were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209”, December 2013.
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 the NADAs listed in this document, and all supplements and amendments thereto, is hereby withdrawn.
Elsewhere in this issue of the *Federal Register,* FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.
Dated: April 4, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.