21 C.F.R. § 522.1450 Moxidectin solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) moxidectin. (b) Sponsor. See No. 000856 in §510.600(c) of this chapter. (c) Related tolerances. See §556.426 of this chapter. (d) Conditions of use in beef and nonlactating dairy cattle—(1) Amount. 0.2 mg/kilogram body weight (0.2 mg/2.2 pound) as a single subcutaneous injection. (2) Indications for use. For treatment and control of gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage larvae, and inhibited larvae), Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-stage larvae), Trichostrongylus colubriformis (adults and fourth-stage larvae), Cooperia oncophora (adults), Cooperia pectinata (adults), Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata (adults), Cooperia surnabada (adults and fourth-stage larvae), Nematodirus helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); grubs: Hypoderma bovis and Hypoderma lineatum; mites: Psoroptes ovis (Psoroptes communis var. bovis); lice: Linognathus vituli and Solenopotes capillatus; for protection of cattle from reinfection with D. viviparus and O. radiatum for 42 days after treatment, with H. placei for 35 days after treatment, and with O. ostertagi and T. axei for 14 days after treatment. (3) Limitations. Do not slaughter cattle within 21 days of treatment. Because a withholding time for milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal. [70 FR 36337, June 23, 2005, as amended at 71 FR 7414, Feb. 13, 2006]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1450 Moxidectin solution.
