83 FR 62 pgs. 13637-13638 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Type: RULEVolume: 83Number: 62Pages: 13637 - 13638
Pages: 13637, 13638Docket number: [Docket No. FDA-2017-N-0002]
FR document: [FR Doc. 2018-06357 Filed 3-29-18; 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 Part 522
[Docket No. FDA-2017-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 three new animal drug applications (NADAs). 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 9, 2018.
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:
During July and August 2017, the following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:
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| File No. | Sponsor | Product name | 21 CFR section |
|---|---|---|---|
| 047-055 | Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880 | Chorionic Gonadotropin Powder for Injection | 522.1081 |
| 104-606 | Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880 | Dexamethasone Sodium Phosphate Injection | 522.540 |
| 139-633 | Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 | WILDNIL (carfentanil citrate) Injection | 522.300 |
Therefore, under authority delegated to the Commissioner of Food and Drugs, and in accordance with §?514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is hereby withdrawn, effective April 9, 2018.
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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06357 Filed 3-29-18; 8:45 am]
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