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FDA finally gives thumbs-up to Entereg
GlaxoSmithKline and Adolor reached the Entereg summit. After a four-year climb, the two companies finally got FDA approval to sell the anti-constipation drug Entereg. It's OK'd for use after abdominal surgery, and will be available under a risk-management program designed to prevent long-term outpatient use. The approval was delayed several times when the agency asked for more data, concerned about side effects such as heart problems that might arise with long-term use.
- here's the release on the approval
- see the story in Forbes
- check out the Philadelphia Inquirer article
Related Articles:
FDA delays Entereg decision
GSK, Adolor face another Entereg delay
Entereg wins key FDA advisory committee vote
Investors cheer FDA's acceptance of Entereg response
FDA wants more safety data on Entereg
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