21 C.F.R. § 522.1362

Current through October 31, 2024
Section 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. 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.

21 C.F.R. §522.1362

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
82 FR 21690, 5/10/2017; 84 FR 39184, 8/9/2019