21 CFR 522.1362 - Melarsomine powder for injection.

§ 522.1362 Melarsomine powder for injection.

(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. 050604 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]

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS