Source: https://www.federalregister.gov/documents/2003/10/22/03-26569/implantation-or-injectable-dosage-form-new-animal-drugs-ceftiofur-crystalline-free-acid
Timestamp: 2017-09-20 02:54:43
Document Index: 542469470

Matched Legal Cases: ['art 522', '§\u2009522', '§\u2009522', '§\u2009510', '§\u2009556', '§\u2009556']

Federal Register :: Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid
A Rule by the Food and Drug Administration on 10/22/2003
This rule is effective October 22, 2003.
68 FR 60296
60296 (1 page)
03-26569
https://www.federalregister.gov/d/03-26569 https://www.federalregister.gov/d/03-26569
Start Preamble Start Printed Page 60296
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pharmacia & Upjohn Co. The NADA provides for the veterinary prescription use of ceftiofur crystalline free acid suspension in beef and nonlactating dairy cattle, by subcutaneous injection in the ear, for the treatment and control of bovine respiratory disease (BRD).
Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, filed NADA 141-209 for NAXCEL XT (ceftiofur crystalline free acid) Sterile Suspension. The NADA provides for the veterinary prescription use of ceftiofur crystalline free acid suspension in beef and nonlactating dairy cattle, by subcutaneous injection in the ear, for the treatment of BRD (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somnus and for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somnus. The application is approved as of September 5, 2003, and the regulations are amended in 21 CFR part 522 by adding new § 522.315 to reflect the approval. In addition, 21 CFR 556.113 is being amended to add an acceptable single-dose intake for residues of ceftiofur at the injection site and a tolerance for residues at the injection site. The basis of approval is discussed in the freedom of information summary.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning September 5, 2003.
2. Section 522.315 is added to read as follows:
§ 522.315
Ceftiofur crystalline free acid.
(a) Specifications. Each milliliter of suspension contains 200 milligrams (mg) ceftiofur equivalents (CE).
(b) Sponsor. See No. 000009 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.113 of this chapter.
(d) Conditions of use in cattle—(1) Amount. 6.6 mg CE per kilogram of body weight by a single, subcutaneous injection in the middle third of the posterior aspect of the ear.
(2) Indications for use. For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somnus. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somnus.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.
4. Section 556.113 is amended by redesignating paragraph (a) as paragraph (a)(1); by adding a new header to paragraph (a); by adding new paragraph (a)(2); and by adding a new sentence to the end of paragraph (b)(2) to read as follows:
§ 556.113
(a) Acceptable daily intake and acceptable single-dose intake—(1) Acceptable daily intake (ADI).* * *
(2) Acceptable single-dose intake (ASDI). The ASDI total residues of ceftiofur is 0.830 milligrams per kilogram of body weight. The ASDI is the amount of total residues of ceftiofur that may safely be consumed in a single meal. The ASDI is used to derive the tolerance for residues of desfuroylceftiofur at the injection site.
(2) * * * The tolerance for residues of desfuroylceftiofur in injection site muscle is 166 parts per million.
Andrew J. Beaulieu,
[FR Doc. 03-26569 Filed 10-21-03; 8:45 am]