Pharmacia Zyvox pediatric approval
This article was originally published in Pharmaceutical Approvals Monthly
Pharmacia will highlight dosing convenience with Zyvox as it enters the pediatric market. The oxazolidinone antibiotic clears FDA Dec. 19 for pediatric use in all approved indications. The range of appropriate pediatric indications was a topic of discussion prior to approval (Pharmaceutical Approvals Monthly, Nov. 1, 2002, p. 3). Linezolid is available both as an I.V. and oral formulation, allowing patients to potentially leave the hospital earlier while continuing therapy. The sNDA, submitted June 24, received a priority revie
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