U.S. FDA staff questions J&J antibiotic studies

U.S. drug reviewers have “several major concerns” about the effectiveness data supplied by Johnson & Johnson in a bid to expand the use of its antibiotic Doribax (doripenem for injection), according to documents released on Monday.

The Food and Drug Administration will ask an advisory panel that meets Wednesday if the company has demonstrated Doribax is safe and effective for hospital-acquired pneumonia and ventilator-associated pneumonia. The drug is already approved for treating other infections.

Concerns include questions about the interpretation of chest X-rays, a summary from the FDA staff said.

WASHINGTON (Reuters)