Roche Rocephin injection for otitis media approved Dec. 23 as first single-dose regimen for indication.

Executive Summary

ROCHE ROCEPHIN IS FIRST SINGLE-DOSE OTITIS MEDIA ANTIBIOTIC following approval of Roche's supplemental NDA 50-585/S-046 by FDA on Dec. 23. The new indication for Rocephin (ceftriaxone) intramuscular injection covers acute otitis media due to Streptococcus pneumoniae and beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis. The 13 other antibiotics approved for otitis media are all orally administered and require a five- to 10-day dosing regimen, which can complicate compliance.