At Tuesday's meeting, the FDA will ask members of its anti-infective drugs advisory committee whether the benefits of Factive outweigh its risks as a treatment for acute sinusitis.
The Food and Drug Administration should require an additional year of pediatric adverse event reporting on three drugs that received pediatric exclusivity in 2002, the FDA's pediatric subcommittee of the Anti-Infective Drugs Advisory Committee agreed.
Food and Drug Administration (FDA) has posted on its website briefing documents for the November 19, 2008 Anti-Infective Drugs Advisory Committee (AIDAC) meeting.
Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee will review the Company's New Drug Application (NDA) for oritavancin on November 19, 2008.
Food and Drug Administration (FDA) has informed Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) that the FDA's Anti-Infective Drugs Advisory Committee will review the supplemental New Drug Application (sNDA) for FACTIVE(R) (gemifloxacin mesylate) tablets for the treatment of acute bacterial sinusitis (ABS) on September 12, 2006.
