(a) Specifications. Each tablet contains 50 or 150 milligrams (mg) masitinib mesylate.
(b) Sponsor. See No. 052913 in Sec. 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 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. [76 FR 6327, Feb. 4, 2011, as amended at 77 FR 35837, June 15, 2012]