Pfizer Zithromax Otitis Media Single-Dose Needs PK Studies, Cmte. Says
Executive Summary
Pfizer Zithromax one-day and three-day dosing regimens need more pharmacokinetic studies in children with acute otitis media, FDA's Anti-Infective Drugs Advisory Committee recommended Nov. 7
You may also be interested in...
FDA Otitis Media Guidance To Offer “Flexible Approach” To Trial Design
FDA's otitis media guidance will offer a "flexible approach" to designing trials for anti-infective drugs being developed for the condition, the agency said
FDA Otitis Media Guidance To Offer “Flexible Approach” To Trial Design
FDA's otitis media guidance will offer a "flexible approach" to designing trials for anti-infective drugs being developed for the condition, the agency said
GSK Augmentin Response To Zithromax: One-Day Dosing Offset By Vomiting
Increased vomiting associated with one-day Zithromax will be a focal point of GlaxoSmithKline's promotional response to the improved dosing for Pfizer's acute otitis media product