CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.48—Altrenogest.

520.48—Altrenogest.

(a) Specifications. Each milliliter (mL) of solution contains 2.2 milligrams (mg) altrenogest.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.36 of this chapter.
(d) Conditions of use—(1) Horses —(i) Amount. 1.0 mL per 110 pounds body weight (0.044 mg/kg) daily for 15 consecutive days.
(ii) Indications for use. For suppression of estrus in mares.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine— (i) Amount. Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days by top-dressing on a portion of each gilt's daily feed.
(ii) Indications for use. For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.
(iii) Limitations. Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis). Gilts must not be slaughtered for human consumption for 21 days after the last treatment.

Code of Federal Regulations

[66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, 2008; 74 FR 61516, Nov. 25, 2009]