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New Animal Drugs; Change of Sponsor's Name

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Information about this document as published in the Federal Register.

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Final rule.


The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Nycomed US, Inc., to Fougera Pharmaceuticals, Inc.


This rule is effective January 27, 2012.


Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, (240) 276-8300, email:


Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747 has informed FDA of a change of name to Fougera Pharmaceuticals, Inc. Accordingly, the Agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 510

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows:


1. The authority citation for

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Nycomed US, Inc.”; alphabetically add a new entry for “Fougera Pharmaceuticals, Inc.”; and in the table

The addition and revision read as follows:

Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747025463
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
025463Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747.
*    *    *    *    *

Dated: January 24, 2012.

William T. Flynn,

Acting Director, Center for Veterinary Medicine.

[FR Doc. 2012-1756 Filed 1-26-12; 8:45 am]