Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.

(a) Specifications. Each gram of suspension contains 10 milligrams (mg) orbifloxacin, mometasone furoate monohydrate equivalent to 1 mg mometasone furoate, and 1 mg posaconazole. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. For dogs weighing less than 30 lbs. instill 4 drops once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops into the ear canal. Therapy should continue for 7 consecutive days. (2) Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase-positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 16346, Apr. 1, 2010]