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GSK Tackles Rotarix Risks Head On, Clearing Way For Panel’s Support

Executive Summary

With a positive advisory committee recommendation, GlaxoSmithKline's rotavirus vaccine Rotarix is proving to be a successful example of handling a known risk factor by working closely with FDA, prospectively assessing the risk potential and developing a comprehensive pharmacovigilance plan

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Rotarix Launch Planned For Second Half; GSK Touts Quick Dosing Schedule

GlaxoSmithKline will launch its rotavirus gastroenteritis vaccine Rotarix in the U.S. in the second half of the year after FDA granted approval April 3. The two-course vaccine will offer a dosing advantage over Merck's existing rotavirus vaccine RotaTeq, which is administered over three courses

Rotarix Launch Planned For Second Half; GSK Touts Quick Dosing Schedule

GlaxoSmithKline will launch its rotavirus gastroenteritis vaccine Rotarix in the U.S. in the second half of the year after FDA granted approval April 3. The two-course vaccine will offer a dosing advantage over Merck's existing rotavirus vaccine RotaTeq, which is administered over three courses

Merck RotaTeq Observational Study For Intussusception Will Enroll 28,000

A post-marketing observational study for Merck's RotaTeq will enroll 28,000 patients to track reports of intussusception and other potential adverse events, the company told FDA's Vaccines & Related Biological Products Advisory Committee at its Dec. 14 meeting

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