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Oncologic Accelerated Approval Phase IV Studies For 7 Drugs To Be Reviewed

Executive Summary

Accelerated approval Phase IV commitments for seven oncologic products will be reviewed at the March 12-13 meeting of FDA's Oncologic Drugs Advisory Committee

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AstraZeneca Prilosec generic erosion: AstraZeneca's Prilosec holds 47% share of total prescriptions following generic omeprazole entry in late 2002, CFO Jon Symonds says on Jan. 30 investor call. "We must, of course, be cautious with only six weeks of data available...but it's clear that the erosion rate is significantly less than that observed with either Prozac or Zestril at a similar stage, seemingly consistent with Kudco's inability to fully supply the market." Schwarz' subsidiary Kudco is distributing generic Prilosec on a limited basis due to supply constraints (1"The Pink Sheet" Dec. 16, 2002, p. 30)....Nexium ramp-up: Nexium total prescription share is over 20%, up more than eight percentage points in 2002. Share of total scripts written by gastrointestinal specialists is more than 27%...

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