Code · CFR · Title 21 — Food and Drugs · Part 522 — Implantation or Injectable Dosage Form New Animal Drugs · § 522.2450

§ 522.2450. Tigilanol.

102 words·~1 min read·/us/cfr/t21/s§ 522.2450

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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]