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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES > SUBPART E—Conditionally Approved New Animal Drugs For Minor Use and Minor Species (§516.1215 to §516.1318) > 516.1318—Masitinib.

CFR

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.

Code of Federal Regulations

[76 FR 6327, Feb. 4, 2011]
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