Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US regulators have rejected Labopharm's appeal to overturn a previous decision to deny immediate approval of its once-daily pain pill tramadol. The drug developer is now set to take its appeal to the next supervisory level.
Subscribe to our email newsletter
Labopharm initiated the formal dispute resolution process in October 2007 after receiving an approvable letter from the FDA for its once-daily formulation of tramadol in May.
The FDA has said that Labopharm did not demonstrate the drug’s effectiveness since the methods used to analyze clinical trial data did not address missing data from patients who had dropped out of the study.