- (a) Specifications. Each milliliter (mL) of solution contains 1 milligram tigilanol tiglate.
- (b) Sponsor. See No. 086132 in § 510.600(c) of this chapter.
- (c) Conditions of use in dogs—(1) Amount. Administer as an intratumoral injection at a dose of 0.5 mL per cubic centimeter of tumor volume.
- (2) Indications for use. For the treatment of non-metastatic cutaneous mast cell tumors and non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock in dogs.
- (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[86 FR 17064, Apr. 1, 2021]