Caption: The FDA's Anti-Infective Drugs Advisory Committee
voted 11-0 that there was "substantial evidence" that isavuconazonium was safe and effective for the treatment of invasive aspergillosis, a life-threatening condition.
At a meeting, the FDA's Anti-Infective Drugs Advisory Committee
concluded that phase II clinical data indicated the drug significantly shortened the time to sputum culture conversion, a surrogate marker for clinical effectiveness, when added to standard background treatment in adults with multidrug-resistant (MDR) TB.
He alleged that FDA managers failed to notify the Anti-Infective Drugs Advisory Committee
when it met in 2003 that the agency had concerns about study 3014's integrity.
During Food and Drug Administration approval hearings for drotrecogin alfa, members of the Anti-Infective Drugs Advisory Committee
noted that the drug was less effective in reducing mortality in patients with less severe sepsis, who had a better prognosis.
Pharmacokinetics and safety studies of antiretroviral drugs under development for infants infected with HIV should continue, according to a Food and Drug Administration pediatric subcommittee of the Anti-Infective Drugs Advisory Committee
The FDA's Anti-Infective Drugs Advisory Committee
voted 11 to 2 that the safety and effectiveness data presented did not demonstrate an acceptable risk-benefit profile of a 5-day course of gemifloxacin for treating acute bacterial sinusitis (ABS).
Cardiac imaging drugs deserve more study in pediatric patients, panel members concluded at a meeting of the Food and Drug Administration's Anti-Infective Drugs Advisory Committee
If an agreement on labeling can't be reached, FDA refers the issue to a pediatric advisory panel within the agency's Anti-Infective Drugs Advisory Committee
, which has 90 days to review the label language and make any recommendations on label changes.
At the meeting of the FDA anti-infective drugs advisory committee
in October, Eli Lilly reported that as of Sept.