GroundRules
21 CFR 522.2450: Tigilanol.
Where this section sits in the code
- 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
- PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON