Forest Antibiotic Deemed Effective Ahead of Advisory Panel

Forest Laboratories’ antibiotic ceftaroline has received positive feedback from FDA drug reviewers ahead of its consideration by the agency’s Anti-Infective Drugs Advisory Committee today. The drug met pre-specified efficacy endpoints and showed trends favoring its use over Roche’s antibiotic Rocephin (ceftriaxone) for the treatment of community-acquired pneumonia, according to briefing documents released by the FDA. Community-acquired pneumonia and complicated skin and structure infections are the two indications being sought by Forest for the drug. The user fee action goal date is in late October.
Drug Industry Daily