2010-21296. New Animal Drugs; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications; Deslorelin Acetate; Dichlorophene and Toluene Capsules; Pyrantel Pamoate Suspension

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 Peptech Animal Health Pty, Ltd. to Dechra, Ltd. and for an abbreviated new animal drug application (ANADA) from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc. In addition, FDA is removing those portions of the regulations that reflect approval of two other NADAs transferred from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc., for which voluntary withdrawal of approval was requested after the change of sponsorship. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these two NADAs.

DATES:

This rule is effective:

1. August 27, 2010 for 21 CFR 510.600(c), 520.2043, and 522.533.

2. September 7, 2010 for 21 CFR 520.580.

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:

Church & Dwight Co., Inc., 469 North Harrison St., Princeton, NJ 08543-5297, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 101-497 and NADA 101-498 for oral capsules containing dichlorophene and toluene, and ANADA 200-028 for an oral suspension of pyrantel pamoate to Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514. Accordingly, the agency is amending the regulations in 21 CFR 520.2043 to reflect the transfer of ownership.

Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd., Macquarie Park, New South Wales 2113, Australia, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-044 for subcutaneous implants containing deslorelin acetate to Dechra, Ltd., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom. Accordingly, the agency is amending the regulations in 21 CFR 522.533 to reflect the transfer of ownership and a current format.

Following these changes of sponsorship, Pegasus Laboratories, Inc., has requested that FDA withdraw approval of the two NADAs for dichlorophene and toluene capsules because they are no longer manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 101-497 and 101-498, and all supplements and amendments thereto, is withdrawn, effective September 7, 2010. As provided in the regulatory text of this document, the agency is amending the regulations in 21 CFR 520.580 to reflect these withdrawals of approval.

Also, following these changes of sponsorship, Church & Dwight Co., Inc., and Peptech Animal Health Pty, Ltd., are no longer sponsors of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for these firms.

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 Parts 520 and 522

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 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.

§ 510.600

[Amended]

2. In § 510.600, in the table in paragraph (c)(1), remove the entries for “Church & Dwight Co., Inc.” and “Peptech Animal Health Pty, Ltd.”; and in the table in paragraph (c)(2), remove the entries for “010237” and “064288”.

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 520 continues to read as follows:

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

§ 520.580

[Amended].

4. In paragraph (b)(1) of § 520.580, remove “010237,”.

§ 520.2043

[Amended]

5. In paragraph (b)(2) of § 520.2043, remove “010237” and in its place add “055246”.

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

7. In § 522.533, revise the section heading and paragraph (b), add paragraph (c), and remove paragraph (d) to read as follows:

§ 522.533

Deslorelin.

(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.

(c) Conditions of use in horses and ponies—(1) Amount. One implant per mare subcutaneously in the neck.

(2) Indications for use. For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 millimeters in diameter.

(3) Limitations. Do not use in horses or ponies intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: August 23, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.