Saturday, October 21, 2000
What's the Buzz?
Bid on hold to put Prilosec on shelves
A federal advisory panel Friday decided against backing a version of the heartburn treatment Prilosec, undermining Procter & Gamble's bid to market the drug as a non-prescription medication.
P&G and AstraZeneca Plc have been working on a non-prescription version of Prilosec for the past few years.
The two co-market the prescription version of the drug, which raked in $4.2 billion in sales last year worldwide.
The advisory committee decided an over-the-counter (OTC) version couldn't be demonstrated to be significantly more effective than a placebo.
An advisory committee's opinion is important because the Food and Drug Administration usually follows its panel's advice.
Panelists said the drug could be approved someday for over-the-counter use , Bloomberg News reported, though winning approval would likely require additional studies and a more complete, easier-to-understand label.
We are encouraged. ... It's quite common for the committee to request additional data for a first-in-class Rx-to-OTC switch, said Tom Blinn, P&G's vice president of OTC healthcare in a prepared statement.
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Tristate Summary
What's the Buzz?