Federal Register - October 20, 2021
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Source: Federal Register
57996
Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations Drug labeler code
Firm name and address
2
Drug labeler code
Firm name and address
065085
Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India
069043
Cronus Pharma Specialities India Private Ltd., Sy No99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India
086121
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807
PART 516NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
3. The authority citation for part 516
continues to read as follows:
Authority: 21 U.S.C. 360ccc, 360ccc2, 371.
4. Add 516.1858 to subpart E to read as follows:
516.1858
Potassium bromide.
a Specifications. Each chewable tablet contains 250 or 500 milligrams mg potassium bromide.
b Sponsor. See No. 055246 in 510.600c of this chapter.
c Conditions of use1 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.
5. Add 516.2980 to subpart E to read as follows:
lotter on DSK11XQN23PROD with RULES1
516.2980
Verdinexor.
a Specifications. Each tablet contains 2.5, 10, or 50 milligrams mg verdinexor.
b Sponsor. See No. 086121 in 510.600c of this chapter.
c Conditions of use1 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
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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.
PART 520ORAL DOSAGE FORM
NEW ANIMAL DRUGS
6. The authority citation for part 520
continues to read as follows:
Authority: 21 U.S.C. 360b.
7. In 520.441, revise paragraph b1
to read as follows:
520.441
Chlortetracycline powder.
b
1 Nos. 000010, 054771, and 069254
for use as in paragraph d of this section.
8. In 520.455, revise the section heading and paragraph b to read as follows:
520. 455
Clomipramine.
b Sponsors. See Nos. 051311 and 086039 in 510.600c of this chapter.
9. In 520.905c, revise paragraph e2 to read as follows:
520.905c
Fenbendazole paste.
e
2 Beef and dairy cattlei Amount.
Administer orally 2.3 mg/lb 5 mg/kg body weight.
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ii Indications for use. For the treatment and control of: Lungworms:
Adult Dictyocaulus viviparus;
Stomach worms: Adult brown stomach worms Ostertagia ostertagi, adult and fourth-stage larvae barberpole worms Haemonchus contortus, fourth-stage larvae barberpole worms H. placei, and adult and fourth-stage larvae small stomach worms Trichostrongylus axei;
Intestinal worms adult and fourth-stage larvae: Hookworms Bunostomum phlebotomum, thread-necked intestinal worms Nematodirus helvetianus, small intestinal worms Cooperia punctata and C. oncophora, bankrupt worms Trichostrongylus colubriformis, and nodular worms Oesophagostomum radiatum.
iii Limitations. Milk taken during treatment and for 96 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. 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 preruminating calves.
10. In 520.1189, revise paragraph b to read as follows:
520.1189
Itraconazole.
b Sponsor. See No. 051311 in 510.600c of this chapter.
11. In 520.1248, revise paragraphs b and c1 to read as follows:
520.1248
Levothyroxine.
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