(a) Specifications. The drug consists of a vial of lyophilized powder containing 50 milligrams of melarsomine dihydrochloride which is reconstituted with the provided 2 milliliters of sterile water for injection.

(b) Sponsor. See Nos. 000010 and 086073 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer only by deep intramuscular injection in the lumbar muscles (L3-L5).

(2) Indications. Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs.

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

[60 FR 49340, Sept. 25, 1995, as amended at 79 FR 16191, Mar. 25, 2014; 82 FR 21690, May 10, 2017; 84 FR 39184, Aug. 9, 2019]