§ 522.2450 Tigilanol.
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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
Specifications.(a) Each milliliter (mL) of solution contains 1 milligram tigilanol tiglate.
Sponsor.(b) See No. 086132 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer as an intratumoral injection at a dose of 0.5 mL per cubic centimeter of tumor volume.
Indications for use.(2) 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.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[86 FR 17064, Apr. 1, 2021]
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