E9-29494. New Animal Drugs; Change of Sponsor; Azaperone

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Schering-Plough Animal Health Corp. to Janssen Pharmaceutica NV.

DATES:

This rule is effective December 11, 2009.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 115-732 for STRESNIL (azaperone) Injection to Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. Accordingly, the agency is amending the regulations in 21 CFR 522.150 to reflect the transfer of ownership and a current format.

In addition, Janssen Pharmaceutica NV is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to add entries for this sponsor.

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

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 522

• Animal drugs

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 parts 510 and 522 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

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

2. In § 510.600, in the table in paragraph (c)(1), alphabetically add an entry for “Janssen Pharmaceutica NV”; and in the table in paragraph (c)(2), numerically add an entry for “012578” to read as follows:

§ 510.600

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

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*    *    *    *    *
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium	012578
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
012578	Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
*    *    *    *    *

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

4. Revise § 522.150 to read as follows:

§ 522.150

Azaperone.

(a) Specifications. Each milliliter of solution contains 40 milligrams (mg) azaperone.

(b) Sponsor. See No. 012578 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Indications for use. For control of aggressiveness when mixing or regrouping weanling or feeder pigs weighing up to 80 pounds.

(2) Dosage. 2.2 mg per kilogram (1 mg per pound) by deep intramuscular injection.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: December 7, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.