21 CFR § 520.2654 Oral Dosage Form New Animal Drugs

§ 520.2654 Velagliflozin.

Current through Sep 8, 2026 · Read all of Part 520

(a) Specifications. Each milliliter of solution contains 15 milligrams (mg) velagliflozin.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer orally 0.45 mg per pound of body weight (1 mg per kilogram) velagliflozin once daily.

(2) Indications for use. To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[88 FR 84700, Dec. 6, 2023]

← § 520.2645 Tylvalosin.§ 520.2700 Verdinexor tablets. →