21 CFR §522.1362

1. (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.
2. (b)Sponsor. See Nos. 000010 and 086073 in § 510.600(c) of this chapter.
3. (c)Conditions of use—(1) Amount. Administer only by deep intramuscular injection in the lumbar muscles (L3-L5).
   1. (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.
   2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.