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| Subpart E | Conditionally Approved New Animal Drugs For Minor Use and Minor Species | 516.498 – 516.2475 | ||||||||||||||||||||||||||||||
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72 FR 41017, July 26, 2007, unless otherwise noted.
72 FR 57200, Oct. 9, 2007, unless otherwise noted.
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72 FR 57200, Oct. 9, 2007, unless otherwise noted.
(a) Specifications. Each delayed-release tablet contains 125 milligrams (mg) crofelemer.
(b) Sponsor. See No. 086149 in § 510.600(c) of this chapter.
(c) Conditions of use —
(1) Amount. Administer 1 tablet orally twice daily for 3 days for dogs weighing ≤140 pounds. Administer 2 tablets orally twice daily for 3 days for dogs weighing >140 pounds.
(2) Indications for use. For the treatment of chemotherapy-induced diarrhea in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[87 FR 17944, Mar. 29, 2022. Redesignated at 88 FR 16546, Mar. 20, 2023]
(a) Specifications. Each milliliter of solution contains 10 milligrams of doramectin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in cattle —
(1) Amount. 200 micrograms per kilogram (10 milligrams per 110 pounds).
(2) Indications for use. For prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis), and prevention of reinfestation for 21 days.
(3) Limitations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Administer as a single subcutaneous or intramuscular injection. Do not slaughter cattle for human consumption within 35 days of treatment. Not for use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
[91 FR 5300, Feb. 6, 2026, as amended at 91 FR 41558, July 7, 2026]
(a) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) of fluralaner
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —
(1) Amount. 2.5 mg per kilogram (1.13 mg per one pound).
(2) Indications for use. For the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick (Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Environmental temperature affects the withdrawal period. Cattle must not be slaughtered for human consumption within 98 days of treatment. If cattle are continuously exposed to temperatures at or above 60 °F after product administration, then cattle may be slaughtered for human consumption 44 days after treatment. Violative residues may result if cattle are exposed to temperatures below 60 °F after administration and are slaughtered at 44 days. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows: use in these cattle may cause drug residues in milk and/or calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.
[91 FR 41559, July 7, 2026]
(a) Specifications. The drug is provided as a powder for injection that is reconstituted with 3.5 milliliter (mL) of provided diluent to a final concentration of 4 milligrams (mg) fuzapladib sodium per mL.
(b) Sponsor. See No. 064642 in § 510.600(c) of this chapter.
(c) Conditions of use —
(1) Amount. Administer at a dosage of 0.4 mg (0.1 mL) per kilogram of body weight once daily for 3 consecutive days by intravenous (IV) injection over 15 seconds to 1 minute.
(2) Indications for use in dogs. For the management of clinical signs associated with acute onset of pancreatitis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[88 FR 16546, Mar. 20, 2023]
(a) Specifications. Each chewable tablet contains:
(1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg praziquantel, and 14.25 mg pyrantel (as pamoate salt);
(2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, and 28.5 mg pyrantel (as pamoate salt);
(3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 57 mg pyrantel (as pamoate salt);
(4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 114 mg pyrantel (as pamoate salt); or
(5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 228 mg pyrantel (as pamoate salt).
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —
(1) Amount. Administer orally at the minimum dosage of 9 mg/pound (mg/lb) (20 mg/kilogram (mg/kg)) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt).
(2) Indications for use. For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[91 FR 20340, Apr. 16, 2026]
(a) Specifications. Each milliliter (mL) of suspension contains 25 milligrams (mg) molidustat sodium.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —
(1) Amount. Administer orally at a dosage of 5 mg/kg of body weight (2.3 mg/lb) daily for up to 28 consecutive days.
(2) Indications for use. For the control of nonregenerative anemia associated with chronic kidney disease in cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[88 FR 55563, Aug. 16, 2023]
(a) Specifications. Each tablet contains 15, 16.2, 30, 32.4, 60, 64.8, 97.2 or 100 milligrams (mg) phenobarbital.
(b) Sponsor. See No. 064950 in § 510.600(c) of this chapter.
(c) Conditions of use —
(1) Amount. Administer phenobarbital as tablets given orally twice a day at the minimum dosage of 2.5 mg per kilogram of body weight (mg/kg) and may be titrated to effect to a maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should be adjusted based on monitoring the clinical response of the individual patient.
(2) Indications for use. For the control of seizures associated with idiopathic epilepsy in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[88 FR 84699, Dec. 6, 2023; 89 FR 85426, Oct. 28, 2024]
(a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or 10 milligrams (mg) pimobendan.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use —
(1) Amount. Administer orally at a total daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into two portions administered approximately 12 hours apart.
(2) Indications for use in dogs. For the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease (2019 ACVIM Consensus Statement). Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[87 FR 76421, Dec. 14, 2022]
(a) Specifications. Each sustained-release tablet contains 0.4, 1.2, or 2.4 milligrams (mg) sirolimus.
(b) Sponsor. See No. 086169 in § 510.600(c) of this chapter.
(c) Conditions of use in cats —
(1) Amount. Administer orally once weekly at a dose of 0.3 mg/kilogram of bodyweight.
(2) Indications for use. For the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[90 FR 19624, May 9, 2025]
(a) Specifications. Each milliliter of solution contains 0.2 milligrams (mg) torsemide.
(b) Sponsor. See No. 017030 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —
(1) Amount. Administer orally once daily at a dose of 0.05 to 0.2 mg/lb (0.11 to 0.44 mg/kg) of bodyweight.
(2) Indications for use. For use as concurrent therapy with pimobendan, spironolactone, and an angiotensin converting enzyme (ACE) inhibitor for the management of pulmonary edema in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[89 FR 85426, Oct. 28, 2024]