Drug Development

Phase III trial of Amoxicillin Pulsys to begin

Published in Drug Week, December 2nd, 2005

Advancis Pharmaceutical Corp. (AVNC) has concluded a pre-phase III meeting with the Food and Drug Administration (FDA), which focused on Advancis' adult and adolescent product development program for Amoxicillin Pulsys.

Based on the outcome of the meeting, the company believes its planned phase III clinical trial design and its regulatory strategy for Amoxicillin Pulsys for adults and adolescents with pharyngitis/tonsillitis were acceptable to the FDA. Advancis is now ready to begin the phase III trial and expects to start enrolling patients later this month.

"We are very pleased to be moving forward with our phase III trial program for Amoxicillin...

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Source: Drug Week (2005-12-02)

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