2011-2519. New Animal Drugs; Masitinib

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect conditional approval of an application for a new animal drug intended for a minor use filed by AB Science. The application for conditional approval provides for the veterinary prescription use of masitinib mesylate tablets in dogs.

DATES:

This rule is effective February 4, 2011.

FOR FURTHER INFORMATION CONTACT:

Lisa M. Troutman, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8322, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

AB Science, 3 Avenue George V, 75008 Paris, France, filed an application for conditional approval (141-308) that provides for veterinary prescription use of KINAVET-CA1 (masitinib mesylate) Tablets for the treatment of recurrent (post-surgery) or nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids. In accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act), this drug is conditionally approved as of December 15, 2010, and the regulations in part 516 (21 CFR part 516) are amended by adding new § 516.1318.

In addition, AB Science has not been previously 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 firm.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support conditional approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

KINAVET-CA1 (masitinib mesylate) Tablets for the intended uses conditionally approved by FDA under application number 141-308 qualifies for 7 years of exclusive marketing rights beginning on the date of conditional approval. This new animal drug qualifies for exclusive marketing rights under section 573(c) of the FD&C Act (21 U.S.C. 360ccc-2(c)) because it has been declared a designated new animal drug by FDA under section 573(a) of the FD&C Act.

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 516

• Administrative practice and procedure
• Animal drugs
• Confidential business information
• Reporting and recordkeeping requirements

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 and 516 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 “AB Science”; and in the table in paragraph (c)(2), numerically add an entry for “052913” 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
*    *    *    *    *
AB Science, 3 Avenue George V, 75008 Paris, France	052913
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
052913	AB Science, 3 Avenue George V, 75008 Paris, France.
*    *    *    *    *

PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

3. The authority citation for 21 CFR part 516 continues to read as follows:

Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

4. Add § 516.1318 to subpart E to read as follows:

§ 516.1318

Masitinib.

(a) Specifications. Each tablet contains 50 or 150 milligrams (mg) masitinib mesylate.

(b) Sponsor. See No. 052913 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. 12.5 mg/kilograms (5.7 mg/lb) of body weight daily.

(2) Indications for use. For the treatment of recurrent (post-surgery) or nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

Dated: January 28, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.