Resources for Food and Drug Administration (FDA)

A Pre-Emptive Strike on the FDA

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Considering that it's been three years since Adolor (Nasdaq: ADLR) first tried to get approval for its lead drug, I'm sure another three-month wait for an FDA decision on the company's top drug isn't going to bother longtime investors too much.

Last week, the FDA informed Adolor and partner GlaxoSmithKline (NYSE: GSK) that they'd likely have to wait another three months -- until May 10 -- to get a decision on the U.S. marketing application for their post-abdominal-surgery constipation treatment, Entereg.

Adolor was originally expecting to hear back from the FDA by Feb. 10 about the Entereg marketing application. After an advisory-panel hearing to discuss the drug that took place three weeks ago (read about it here and here), Adolor decided to update its marketing application with new information about how it would prevent off-label usage of Entereg. This new data submission is what triggered the extra three-month FDA review time.

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