CFR Subpart E

CFR Subpart E
in effect

21 C.F.R. § 516.498 Crofelemer.

(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.

21 C.F.R. § 516.1012 Fuzapladib.

(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.

21 C.F.R. § 516.1449 Molidustat oral suspension.

(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.

21 C.F.R. § 516.1760 Phenobarbital.

(a) Specifications. Each tablet contains 16.2, 32.4, 64.8, or 97.2 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.

21 C.F.R. § 516.1780 Pimobendan.

(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.

21 C.F.R. § 516.1858 Potassium bromide.

(a) Specifications. Each chewable tablet contains 250 or 500 milligrams (mg) potassium bromide. (b) Sponsor. See No. 055246 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Administer 25 to 68 mg per kilogram (11 to 31 mg per pound) of body weight once daily. The dosage can be divided and should be adjusted to clinical response. (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.

21 C.F.R. § 516.2980 Verdinexor.

(a) Specifications. Each tablet contains 2.5, 10, or 50 milligrams (mg) verdinexor. (b) Sponsor. See No. 086121 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Administer verdinexor tablets orally at an initial dose of 1.25 mg per kilogram (mg/kg) of body weight twice per week with at least 72 hours between doses. If tolerated after 2 weeks, increase the dose to 1.5 mg/kg twice per week with at least 72 hours between doses. (2) Indications for use. For the treatment of lymphoma 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.

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