[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.522]

[Page 229]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.522  Danofloxacin.

    (a) Specifications. Each milliliter of solution contains 180 
milligrams (mg) danofloxacin as the mesylate salt.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.169 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. 6 mg per kilogram of 
body weight by subcutaneous injection. Treatment should be repeated 
approximately 48 hours following the first injection.
    (2) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia (Pasteurella) haemolytica and 
Pasteurella multocida.
    (3) Limitations. Animals intended for human consumption should not 
be slaughtered within 4 days from the last treatment. Do not use in 
cattle intended for dairy production. A withdrawal period has not been 
established for this product in pre-ruminating calves. Do not use in 
calves to be processed for veal. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits the 
extra-label use of this drug in food-producing animals.

[67 FR 78972, Dec. 27, 2002]