80 FR 236 pgs. 76387-76388 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Type: RULEVolume: 80Number: 236Pages: 76387 - 76388
Pages: 76387, 76388Docket number: [Docket No. FDA-2015-N-0002]
FR document: [FR Doc. 2015-31040 Filed 12-8-15; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 558
[Docket No. FDA-2015-N-0002]
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notification of withdrawal.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and two abbreviated new animal drug applications (ANADAs). This action is being taken at the sponsors' requests because these products are no longer manufactured or marketed.
DATES:
Withdrawal of approval is effective December 21, 2015.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The following three sponsors have requested that FDA withdraw approval of the NADAs and ANADAs listed in the following table because the products are no longer manufactured or marketed:
| File No. | Sponsor | Product name | 21 CFR section |
|---|---|---|---|
| 140-680?1 | Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405 | TYLAN (tylosin phosphate) Premix | 558.625 |
| 140-681?1 | Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405 | TYLAN SULFA G (tylosin phosphate and sulfamethazine) Premix | 558.630 |
| 200-028 | Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 | EVICT 300 (pyrantel pamoate) Suspension | 520.2043 |
| 200-383 | Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 | CLINDAROBE (clindamycin) Capsules | 520.446 |
| 1 ?These NADAs were identified as being affected by guidance for industry #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 21 CFR 514.116 Notice of withdrawal of approval of application, notice is given that approval of NADA 140-680, NADA 140-681, ANADA 200-028, and ANADA 200-383, and all supplements and amendments thereto, is hereby withdrawn, effective December 21, 2015.
[top] Elsewhere in this issue of the Federal Register , FDA is amending the animal drug regulations to reflect the voluntary
Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31040 Filed 12-8-15; 8:45 am]
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